PART 888—ORTHOPEDIC DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted. Editorial Note: Nomenclature changes to part 888 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device that has two or more types of uses (e.g., used both as a diagnostic device and as a surgical device) is listed in one subpart only. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. [52 FR 33702, Sept. 4, 1987, as amended at 68 FR 14137, Mar. 24, 2003; 78 FR 18233, Mar. 26, 2013] § 888.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. (c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. § 888.5 Resurfacing technique. Because of resurfacing techniques, certain joint prostheses require far less bone resection than other devices intended to repair or replace the same joint. The amount of bone resection may or may not affect the safety and effectiveness of the implantation of the prosthesis. When a resurfacing technique is used, the name of the prosthesis includes this information. § 888.6 Degree of constraint. Certain joint prostheses provide more constraint of joint movement than others. FDA believes that the degree of constraint is an important factor affecting the safety and effectiveness of orthopedic prostheses. FDA is defining the following standard terms for categorizing the degree of constraint. (a) A “constrained” joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in more than one anatomic plane and consists of either a single, flexible, across-the-joint component or more than one component linked together or affined. (b) A “semi-constrained” joint prosthesis is used for partial or total joint replacement and limits translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no across-the-joint linkage. (c) A “non-constrained” joint prosthesis is used for partial or total joint replacement and restricts minimally prosthesis movement in one or more planes. Its components have no across-the-joint linkage. § 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2321, Jan. 14, 2000] Subpart B—Diagnostic Devices § 888.1100 Arthroscope. (a) Identification. (b) Classification. (2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001] § 888.1240 AC-powered dynamometer. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019] § 888.1250 Nonpowered dynamometer. (a) Identification. (b) Classification. § 888.1500 Goniometer. (a) Identification. (b) Classification. (2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of: (i) The performance standard under part 898 of this chapter, and (ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9. [65 FR 19319, Apr. 11, 2000] § 888.1520 Nonpowered goniometer. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001] § 888.1600 Bone indentation device. (a) Identification. (b) Classification. (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation. (3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance testing must demonstrate: (i) The sterility of the patient-contacting components of the device; and (ii) Validation of reprocessing instructions for any reusable components of the device. (6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (7) Software verification, validation, and hazard analysis must be performed. (8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (9) Labeling must include: (i) Instructions for use; (ii) Validated methods and instructions for reprocessing of any reusable components; (iii) A shelf life for any sterile components; (iv) Information regarding limitations of the clinical significance of the device output; and (v) A detailed summary of the accuracy and precision of the device. [88 FR 755, Jan. 5, 2023] Subpart C [Reserved] Subpart D—Prosthetic Devices § 888.3000 Bone cap. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001] § 888.3010 Bone fixation cerclage. (a) Identification. (b) Classification. § 888.3015 Bone heterograft. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. § 888.3020 Intramedullary fixation rod. (a) Identification. (b) Classification. § 888.3023 In vivo cured intramedullary fixation rod. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical testing must be conducted on the final device to assess burst, abrasion, bending, and torsion in static and dynamic conditions. (ii) Mechanical testing must demonstrate the integrity of the balloon including testing for leaks, ruptures, and release of cured/uncured material. (iii) Performance testing must demonstrate that the device can be inserted and removed. (iv) Performance testing must demonstrate the ability, in the event of a leak, to remove the uncured material from its in vivo location. (v) Performance testing must demonstrate the reliability and accuracy of the curing method used. (vi) Thermal safety testing must be conducted to evaluate the temperature rise during curing. (2) Electrical safety, electromagnetic compatibility (EMC) testing, and electromagnetic interference (EMI) testing must be conducted for all electrical components. (3) All patient-contacting components must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility and pyrogenicity of patient contacting components of the device that are provided sterile. (5) Performance data must validate the reprocessing instructions for any reusable components or instruments. (6) Performance data must support the shelf life of the system by demonstrating continued sterility, package integrity, and system functionality over the established shelf life. (7) Technological characterization of the device must include materials, curing agents, and a description of the operating principles of the device, including the delivery system and devices which initiate the curing process. (8) Labeling must include the following: (i) A detailed summary of the device technical parameters. (ii) Information describing all materials of the device. (iii) Information describing how to perform the procedure and use the device, including the delivery system and devices which initiate the curing process, as well as how to remove the device and any uncured materials. (iv) A shelf life. (v) Validated methods and instructions for reprocessing any reusable components or instruments. [83 FR 26759, June 8, 2018] § 888.3025 Passive tendon prosthesis. (a) Identification. (b) Classification. § 888.3027 Polymethylmethacrylate (PMMA) bone cement. (a) Identification. (b) Classification. [67 FR 46855, July 17, 2002] § 888.3030 Single/multiple component metallic bone fixation appliances and accessories. (a) Identification. (b) Classification. § 888.3040 Smooth or threaded metallic bone fixation fastener. (a) Identification. (b) Classification. § 888.3041 Absorbable metallic bone fixation fastener. (a) Identification. (b) Classification. (1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use. The absorption profile must be characterized to completion (full absorption). The difficulty of any revision surgeries must be documented. (2) Non-clinical performance testing must demonstrate that the product performs as intended under anticipated conditions of use. Testing must: (i) Evaluate the complete degradation profile of the device; (ii) Evaluate the initial mechanical performance; and (iii) Evaluate the mechanical performance as the device degrades. (3) The device must be demonstrated to be biocompatible. (4) The device must be demonstrated to be non-pyrogenic. (5) Performance data must demonstrate the sterility of the device. (6) Performance data must support the labeled shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality ( i.e., (7) Labeling must include: (i) Material composition; (ii) Absorption byproducts; (iii) A detailed summary of the product's technical parameters; (iv) An expiration date/shelf life; (v) Instructions for revision surgery; (vi) Time to complete absorption; and (vii) A summary of clinical data with the device. [91 FR 34148, June 5, 2026] § 888.3043 Screw sleeve bone fixation device. (a) Identification. (b) Classification. (1) In vivo performance testing under anticipated conditions of use must demonstrate: (i) The device provides sufficient stability to allow for fracture healing; and (ii) A lack of adverse biologic response to the implant through histopathological and histomorphometric assessment. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must: (i) Assess the stability of the device in a rescue screw scenario; (ii) Demonstrate that the device can be inserted and removed without damage to the implant or associated hardware; (iii) Demonstrate the device can withstand dynamic loading without device failure; and (iv) Characterize wear particle generation. (3) The device must be demonstrated to be biocompatible. (4) The device must be demonstrated to be non-pyrogenic. (5) Performance data must demonstrate the sterility of the device. (6) Performance data must support the labeled shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the established shelf life. (7) Labeling must include: (i) A detailed summary of the device technical parameters; (ii) Information describing all materials of the device; (iii) Instructions for use, including device removal; and (iv) A shelf life. [87 FR 11294, Mar. 1, 2022] § 888.3044 Resorbable implant for anterior cruciate ligament (ACL) repair. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Post-operative evaluation of knee pain and function; and (ii) Durability as assessed by re-tear or re-operation rate. (2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Device performance characteristics, including resorption and ligament healing at repair site; and (ii) Adverse effects as assessed by gross necropsy and histopathology. (3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Characterization of materials, including chemical composition, resorption profile, and mechanical properties; and (ii) Simulated use testing, including device preparation, device handling, compatibility with other ACL repair instrumentation, and user interface. (4) The device must be demonstrated to be biocompatible. (5) Performance data must demonstrate the device to be sterile and non-pyrogenic. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Labeling must include the following: (i) Identification of device materials and specifications; (ii) A summary of the clinical performance testing conducted with the device; (iii) Instructions for use, including compatibility with other ACL repair instrumentation or devices; (iv) Warnings regarding post-operative rehabilitation requirements; and (v) A shelf life. [87 FR 80041, Dec. 29, 2022] § 888.3045 Resorbable calcium salt bone void filler device. (a) Identification. (b) Classification. [68 FR 32636, June 2, 2003] § 888.3046 Resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the product performs as intended under anticipated conditions of use. Clinical testing must evaluate recurrence of chronic osteomyelitis of long bones. Testing must describe safe aminoglycoside serum levels below toxic concentrations. Imaging data ( e.g., (2) Animal performance testing must demonstrate that the product performs as intended under anticipated conditions of use. Testing must include the following: (i) Testing must characterize the performance of the product in an appropriate animal model. The model must mimic the identified clinical use, e.g., (ii) Testing must be conducted in a relevant animal model to evaluate the pharmacology and toxicology of the final, finished product. (3) Non-clinical performance testing must demonstrate that the product performs as intended under anticipated conditions of use. Testing must characterize the product in appropriate in vitro models. (i) Elution kinetics studies must be conducted to determine the in vitro drug release profile of the aminoglycoside from the product lot(s) used for the clinical performance testing studies. (ii) Dissolution testing must characterize the resorption profile of the product. (iii) The following physical and chemical properties must be characterized for in situ setting products: (A) Setting pH and reaction temperature; (B) Setting and working times; (C) Force required to transfer the product from the mixing container to the site of action; (D) Chemical composition of the in vivo-cured product; and (E) Dimensional stability of the in vivo-cured product. (4) Characterization of the product, including the drug substance and drug constituent part components (as applicable), must demonstrate that critical quality attributes and specifications, including compendial requirements, are met and must include: (i) Identification of, and justification for, the specification for each individual component (including the drug substance) of the drug constituent part of the product. (ii) Confirmation that the specifications for the aminoglycoside and drug constituent part components (if present) conform to any corresponding United States Pharmacopeia (USP) monographs. In addition, the aminoglycoside specification must also include other tests that ensure the quality of the product. These tests may, for example, include appearance, solubility, identification, related substances, ratios of active components, assay measured using high performance liquid chromatography, or potency measured using a bioassay. (iii) Identification of, and justification for, the product specification(s) to be met on release of each batch and on stability, including description, identification, aminoglycoside assay, in vitro elution, degradation products, elemental impurities, content uniformity, residual solvents, sterility, and endotoxin. If the aminoglycoside is prepared as a solution before mixing with the other components, that specification must include appearance, pH, and particulates. (iv) Identification of, and justification for, the specifications that apply to the freshly mixed product (pre-setting configuration) and the mixed product administered from the mixing device/device constituent part and allowed to set over a specified time (post-setting configuration). For in vitro elution/drug release specifications, the acceptance criteria must include data from the product lot(s) used in clinical performance (or equivalent) studies. (A) The specification must include tests adequate to ensure the quality attributes of the pre-setting configuration considering the product design, including but not limited to, tests for appearance, setting time, and injectability or extrusion force. (B) The specification must include tests adequate to ensure the quality attributes of the post-setting configuration considering the product design, including but not limited to, tests for appearance, aminoglycoside assay, aminoglycoside degradants, aminoglycoside elution/drug release, uniformity, sterility, endotoxins, setting reaction temperature, working time, and usable amount of the product. (v) For the specifications noted in paragraphs (b)(4)(i) through (b)(4)(iv) of this section, a description of the analytical procedures and a summary of the analytical procedures development and validation must be provided. For in vitro elution/drug release specifications, data must be provided to demonstrate method adequacy, e.g., (5) An analysis must be provided that identifies and evaluates any contribution to the development and spread of antimicrobial resistance. (6) Susceptibility testing to the aminoglycoside must be conducted for all bacterial isolates identified during the clinical performance testing specified in paragraph (b)(1) of this section. (7) If FDA determines that the clinical performance testing specified in special control (b)(1) of this section is insufficient to evaluate long-term safety of the product, post-market surveillance (PMS) must evaluate new bone formation at the location where the product has been placed in accordance with an FDA-agreed upon protocol. (8) The product, including the delivery device constituent part(s) ( e.g., (9) The product and each of its components ( i.e., (10) Performance data must support the sterility and pyrogenicity of the product. The performance data must confirm that the sterilization process has no significant adverse impact ( e.g., e.g., (11) Performance data must support the claimed expiration dating period/shelf life by demonstrating continued sterility, stability (see paragraph (b)(12)(ii) of this section), package integrity, and product functionality over the identified expiration/shelf life. Data to demonstrate continued sterility, stability, and package integrity must be collected for each component and the final, finished product. In addition, product functionality must be demonstrated for the final finished product. Extension of the expiration/shelf life must be submitted in a premarket notification and supported by the data described in this paragraph. (12) Performance data from testing batches at release and on stability must characterize the drug quality attributes of the final, finished product (see paragraph (b)(4) of this section), demonstrate product specifications are consistently met, and support the claimed expiration/shelf-life date. This information must include the following: (i) Batch Release Testing: Batch release data on multiple lots of the final, finished product manufactured using the proposed commercial process must demonstrate that specifications for each component and the final, finished product are met. Data on multiple lots of the mixed product (pre- and post-setting) obtained when the final, finished product is used according to the directions in the instructions for use must demonstrate that the pre- and post-setting specifications are met. (ii) Stability Testing: The final, finished product manufactured using the proposed commercial process and in the proposed commercial packaging must be stored under tightly controlled conditions and periodically tested to demonstrate the stability of the drug constituent part (all components) and the final, finished product. In addition, at each pre-determined stability time point the product must meet the pre- and post-setting specifications. Testing must include three batches placed under long-term storage and accelerated stability conditions and then one batch placed on long-term stability each year. Testing must verify that the acceptance criteria for each specification are met at each stability time point. Parameters that are not expected to change on stability, e.g., (13) Pharmaceutical manufacturing information must be provided, and appropriate documentation be available on inspection or if requested by FDA, for the drug constituent part and the final, finished product to demonstrate that the production processes are properly developed, conducted, controlled, and monitored. This information must include the following: (i) A description of the manufacturing process and controls, including in-process controls, to ensure consistent quality. Such information may be provided by reference to a drug master file (DMF). (ii) A description of the commercial batch formula, including the quality standard ( e.g., (iii) Information or reference to one or more DMFs regarding the drug substance to understand the impurity profile, and representative COAs for the drug substance to confirm quality. (iv) Identification and qualification of in-process hold times for the drug constituent part, where applicable. (v) A description of how compliance with the current good manufacturing practice (CGMP) requirements is achieved at the facilities manufacturing the drug constituent part and final, finished product. This includes identification of the activities that occur at each site, and for any facilities for which § 211 of this chapter is not the established CGMP operating system, a description of how the facilities perform the responsibilities related to the subset of § 211 requirements established in § 4 subpart A of this chapter. (14) The product must contain a single approved aminoglycoside antibacterial. (15) Labeling must include the following: (i) Identification of the maximum volume of the product that may be safely implanted; (ii) A detailed summary of the product's technical parameters; (iii) An expiration date/shelf life; (iv) A list of probable adverse events associated with the use of the product, including those observed during clinical performance studies; (v) Warning about the risk of antimicrobial resistance and the risk of systemic adverse effects from the aminoglycoside; (vi) Precaution against implanting into patients with calcium metabolism issues; overfilling; adding other substances other than those provided (in absence of data on the use of the product mixed with other substances); overpressuring the product because this may lead to extrusion of the product beyond the site of its intended application and damage to surrounding tissues, and since this may lead to fat embolization or embolization of the product material into the bloodstream; and disturbing the product (over a specific time frame) once it begins to harden; (vii) Instructions about proper placement and containment in the desired treatment area; adequate fixation (as necessary); product working time and setting time with any special instructions with respect to drying the surgical field and/or not irrigating the defect site prior to final setting of the product (for a product intended to set in vivo); how and when excess material should be removed from the defect site; (viii) When available, and according to the timeframe included in the PMS protocol agreed upon with FDA as specified in paragraph (b)(7) of this section, a detailed summary of the PMS data must be provided, including: (A) Updates to the labeling to accurately reflect outcomes or necessary modifications based upon data collected during the PMS experience; and (B) Inclusion of results and adverse events associated with utilization of the product during the PMS. [91 FR 34150, June 5, 2026] § 888.3050 Spinal interlaminal fixation orthosis. (a) Identification. (b) Classification. § 888.3060 Spinal intervertebral body fixation orthosis. (a) Identification. (b) Classification. § 888.3070 Thoracolumbosacral pedicle screw system. (a) Identification. e.g., e.g., (2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems. (b) Classification. (i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section. [66 FR 28053, May 22, 2001, as amended at 81 FR 96373, Dec. 30, 2016] § 888.3075 Posterior cervical screw system. (a) Identification. i.e., e.g., e.g., e.g., Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions ( e.g., (b) Classification. (1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( e.g., (B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal. [84 FR 12092, Apr. 1, 2019] § 888.3080 Intervertebral body fusion device. (a) Identification. (b) Classification. (2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. [72 FR 32172, June 12, 2007] § 888.3083 Spinal spheres for use in intervertebral fusion procedures. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. [88 FR 18990, 18993, Mar. 30, 2023] § 888.3085 Intervertebral body graft containment device. (a) Identification. (b) Classification. (1) Clinical performance testing must include an assessment of any adverse events observed during clinical use, as well as intervertebral body fusion, and compare this to a clinically acceptable fusion rate. (2) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant, as well as the ability of the device to be inserted, deployed, and filled with bone graft consistently. (3) Device must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components, and device-specific instruments. (5) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (6) Labeling must bear all information required for the safe and effective use of the device, specifically including the following: (i) A clear description of the technological features of the device including identification of device materials, compatible components in the fusion construct, and the principles of device operation; (ii) Intended use and indications for use, including levels of fixation; (iii) Identification of magnetic resonance (MR) compatibility status; (iv) Cleaning and sterilization instructions for devices and instruments that are provided nonsterile to the end user; and (v) Detailed instructions of each surgical step, including device removal. [89 FR 71158, Sept. 3, 2024] § 888.3090 Intraoperative orthopedic strain sensor. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be conducted: (i) Mechanical testing to evaluate the effect of the device on the mechanical performance of the implant and to characterize the mechanical limits of the components used with the implant; and (ii) Accuracy and repeatability testing of strain measurements. (2) Usability testing must evaluate the effect of the device on the performance of the surgical procedure. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must support the sterility and shelf life of the patient-contacting components of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance data must validate the reprocessing instructions for reusable components of the device. (7) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (8) Labeling must include the following: (i) A shelf life; (ii) Instructions for use; (iii) Reprocessing instructions for any reusable components; and (iv) A statement that the device is not intended to provide diagnostic information or influence clinical decision making. [86 FR 68405, Dec. 2, 2021] § 888.3100 Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] § 888.3150 Elbow joint metal/polymer constrained cemented prosthesis. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,” (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.” [65 FR 17147, Mar. 31, 2000] § 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis. (a) Identification. (b) Classification. § 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] § 888.3200 Finger joint metal/metal constrained uncemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] § 888.3210 Finger joint metal/metal constrained cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] § 888.3220 Finger joint metal/polymer constrained cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. (b) Classification. § 888.3300 Hip joint metal constrained cemented or uncemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] § 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. (b) Classification. [67 FR 21173, Apr. 30, 2002] § 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 81 FR 8149, Feb. 18, 2016] § 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 81 FR 8149, Feb. 18, 2016] § 888.3340 Hip joint metal/composite semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. (a) Identification. 2 3 (b) Classification. [54 FR 48239, Nov. 22, 1989; 54 FR 51342, Dec. 14, 1989] § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. (a) Identification. (b) Classification. [58 FR 3228, Jan. 8, 1993] § 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. (a) Identification. (b) Classification. § 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996] § 888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996] § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. (a) Identification. (b) Classification. § 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. (a) Identification. (b) Classification. § 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [69 FR 59134, Oct. 4, 2004] § 888.3480 Knee joint femorotibial metallic constrained cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996] § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis. (a) Identification. (b) Classification. [68 FR 14137, Mar. 24, 2003] § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” (vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and (viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.” [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996; 65 FR 17147, Mar. 31, 2000] § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996] § 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. (b) Classification. [68 FR 14137, Mar. 24, 2003] § 888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996] § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. (b) Classification. (2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996] § 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. (b) Classification. § 888.3600 Implantable post-surgical kinematic measurement knee device. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be conducted: (i) Mechanical testing must evaluate the mechanical function (mechanical fatigue, static mechanical strength) and durability of the implant. (ii) Simulated use testing must evaluate the ability of the device to be sized, inserted, and sufficiently secured to any compatible components. (iii) Testing must demonstrate the accuracy, reliability, and reproducibility of kinematic measurements. (iv) Testing must demonstrate diagnostic and therapeutic ultrasound conditions for safe use. (v) Testing must demonstrate that the device performs as intended under anticipated conditions of use demonstrating the following performance characteristics, if applicable: (A) Magnetic pulse output testing; (B) Magnetic and electrical field testing; and (C) Testing of the safety features built into the device. (vi) Testing must demonstrate hermeticity of any electronic component enclosures. (2) Performance testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment. (3) Human factors testing must demonstrate that the intended user(s) can correctly use the device for its intended use, including for implantation and post-procedure data access. (4) Performance data must demonstrate the sterility of the device implant and patient-contacting components. (5) Performance data must validate the reprocessing instructions for the reusable components of the device. (6) The patient-contacting components of the device must be demonstrated to be biocompatible. (7) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (8) Performance testing must demonstrate the electromagnetic compatibility/interference, (EMC/EMI), electrical safety, thermal safety, battery safety, and wireless performance of the device. (9) Software verification, validation, and hazard analysis must be performed. (10) The labeling must include the following: (i) A shelf life; (ii) Physician and patient instructions for use, including images that demonstrate how to interact with the device; (iii) Detailed instruction of the surgical technique; (iv) Hardware and software requirements for interacting with the device; (v) A clear description of the technological features of the device including identification of the device materials, compatible components, and the principles of operation; (vi) Identification of magnetic resonance (MR) compatibility status; (vii) Validated methods and instructions for reprocessing of any reusable components; and (viii) A statement regarding the limitations of the clinical significance of the kinematic data. [88 FR 753, Jan. 5, 2023] § 888.3610 Medial knee implanted shock absorber. (a) Identification. (b) Classification. (1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of improvement of knee function and reduction of osteoarthritis symptoms, including pain and function; and (ii) Evaluation of relevant adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of the mechanical function and durability of the implant (including evaluation of absorber unloading capacity, fretting and corrosion, static strength, wear analysis, and fatigue testing); and (ii) Evaluation of worst-case device range of motion. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile. (5) Performance data must validate the reprocessing instructions for the reusable components of the device. (6) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf-life. (7) A training program must be included so that upon completion of the training program, the user can safely and successfully implant the device. (8) Labeling must include the following: (i) Validated methods and instructions for reprocessing of any reusable components; and (ii) A shelf life. [91 FR 39009, June 29, 2026] § 888.3630 Resorbable shoulder spacer. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of improvement of shoulder function and reduction of symptoms ( e.g., (ii) Evaluation of relevant adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Integrity testing of the device, including mechanical and chemical stability; and (ii) Characterization of the device degradation profile. (3) Animal performance testing must include evaluation of the following: (i) Adverse effects, including gross necropsy and histopathology; and (ii) Device degradation to verify in vitro versus in vivo degradation correlation. (4) All patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Labeling must include the following: (i) Instruction for use, including specific instructions regarding device selection and placement; (ii) A detailed summary of the clinical performance testing with the device, including procedure- and device-related complications or adverse events; and (iii) A shelf life. [87 FR 981, Jan. 6, 2023] § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996] § 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1378-97 “Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.” [52 FR 33702, Sept. 4, 1987, as amended at 65 FR 17148, Mar. 31, 2000] § 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.” [52 FR 33702, Sept. 4, 1987, as amended at 65 FR 17148, Mar. 31, 2000] § 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. (a) Identification. (b) Classification. [66 FR 12737, Feb. 28, 2001] § 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996] § 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. (b) Classification. § 888.3695 Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis. (a) Identification. (b) Classification. (1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of improvement of shoulder function and reduction of symptoms, including pain and function, for the indications for use; and (ii) Evaluation of adverse events, including pain, unanticipated adverse device effects, subsequent surgical interventions, wear of the native bone, osteolysis, loosening and migration, and revision, including revision due to device wear, component dissociation, or device brittle fracture. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of the mechanical function (mechanical fatigue strength including evaluation of fretting and corrosion, static mechanical strength, modular component disassembly strength, and wear analysis) and durability of the implant; and (ii) Evaluation of worst-case device range of motion. (3) All patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile. (5) Performance data must validate the reprocessing instructions for the reusable components of the device. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Labeling must include the following: (i) Validated methods and instructions for reprocessing of any reusable components; and (ii) A shelf life. [91 FR 34154, June 5, 2026] § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. (b) Classification. § 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis. (a) Identification. (b) Classification. § 888.3750 Wrist joint carpal lunate polymer prosthesis. (a) Identification. (b) Classification. § 888.3760 Wrist joint carpal scaphoid polymer prosthesis. (a) Identification. (b) Classification. § 888.3770 Wrist joint carpal trapezium polymer prosthesis. (a) Identification. (b) Classification. § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. (b) Classification. § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996] § 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. (b) Classification. § 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis. (a) Identification. (b) Classification. Subpart E—Surgical Devices § 888.4150 Calipers for clinical use. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001] § 888.4200 Cement dispenser. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001] § 888.4210 Cement mixer for clinical use. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001] § 888.4220 Cement monomer vapor evacuator. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 66 FR 38815, July 25, 2001] § 888.4230 Cement ventilation tube. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001] § 888.4300 Depth gauge for clinical use. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001] § 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation. (a) Identification. e.g., (b) Classification. (1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant. (2) The patient contacting components of the device must be demonstrated to be biocompatible. (3) Labeling must include: (i) Identification of implant(s) and instruments which have been validated for use together; and (ii) Validated methods and instructions for reprocessing any reusable parts. [84 FR 57321, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020] § 888.4510 Manual surgical instrument for appropriate patient selection for orthopedic implant. (a) Identification. (b) Classification. (1) Technical specifications regarding geometry of the instruments must be identified and validated to demonstrate that the instruments accurately measure the critical geometry for patient selection of the intended orthopedic implant. (2) The use of the instruments is validated to demonstrate that the measurement process does not alter the patient anatomy which is being measured. (3) The patient contacting components of the device must be demonstrated to be biocompatible. (4) Labeling must include: (i) Identification of orthopedic implant(s) and instruments which have been validated for use together; and (ii) Validated methods and instructions for reprocessing any reusable parts. [91 FR 20351, Apr. 16, 2026] § 888.4515 Orthopedic manual surgical instrumentation for use with total disc replacement devices. (a) Identification. (b) Classification. (1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant. (2) The patient contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated. (4) Labeling must include: (i) Identification of implant(s) and instruments which have been validated for use together; and (ii) Validated methods and instructions for reprocessing any reusable parts. [90 FR 40734, Aug. 21, 2025] § 888.4520 Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices. (a) Identification. (b) Classification. (1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant. (2) The patient contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated. (4) Labeling must include: (i) Identification of implant(s) and instruments which have been validated for use together; and (ii) Validated methods and instructions for reprocessing any reusable parts. [90 FR 40732, Aug. 21, 2025] § 888.4540 Orthopedic manual surgical instrument. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001] § 888.4560 Intraoperative surgical angle measurement tool. (a) Identification. (b) Classification. (1) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of system-level accuracy and validation of procedural accuracy in simulated use. (2) Usability testing must demonstrate that the intended user(s) can correctly use the device based on the instructions for use. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must support the sterility and shelf-life of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance data must demonstrate the electrical safety, electromagnetic compatibility, and wireless coexistence of the device. (7) Labeling must include: (i) A detailed summary of the device technical parameters; (ii) Information regarding limitations of the clinical significance of the device output; (iii) A detailed summary of the accuracy and precision of the device; (iv) Validated methods and instructions for reprocessing of any reusable components; and (v) The shelf-life of the device. [91 FR 46723, July 24, 2026] § 888.4580 Sonic surgical instrument and accessories/attachments. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019] § 888.4600 Protractor for clinical use. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001] § 888.4800 Template for clinical use. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001] § 888.5850 Nonpowered orthopedic traction apparatus and accessories. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 888.5890 Noninvasive traction component. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 66 FR 38815, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 888.5940 Cast component. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 888.5960 Cast removal instrument. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001] § 888.5980 Manual cast application and removal instrument. (a) Identification. (b) Classification. [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 66 FR 38816, July 25, 2001; 90 FR 55993, Dec. 4, 2025]