← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K243571 # Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571) _Zimmer Biomet · JDI · Jul 31, 2025 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K243571 ## Device Facts - **Applicant:** Zimmer Biomet - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Jul 31, 2025 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Acetabular Liners: The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage. Constrained Liners: The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. ## Device Story Acetabular liners and constrained liners for total hip arthroplasty; used with Trabecular Metal Acetabular Revision System shell. Liners manufactured from Longevity highly cross-linked UHMWPE; constrained liners include titanium alloy constraining ring. Devices implanted by orthopedic surgeons in clinical settings. Constrained liners provide mechanical stability for patients at high risk of dislocation. Subject device maintains identical design, materials, and intended use as predicates; differences in sterilization method validated to ensure equivalent sterility assurance. Benefits include restoration of joint function and reduced risk of dislocation in complex revision cases. ## Clinical Evidence No clinical testing was conducted. Substantial equivalence supported by non-clinical bench testing including lever out, torque-out, dynamic impingement, push-out, liner-head pull out, polyethylene wear, and range of motion assessments. Biocompatibility testing performed per ISO 10993-1 and 21 CFR 58. ## Technological Characteristics Materials: Longevity highly cross-linked UHMWPE (conforms to ASTM F648) and titanium alloy constraining ring. Components are sterile, single-use. Design features and materials are identical to predicate devices. Sterilization method differs from predicate but maintains equivalent sterility assurance level. ## Regulatory Identification A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Trabecular Metal Revision Shell Liners ([K051516](/device/K051516.md)) - Trabecular Metal Acetabular Revision System Cemented Constrained Liner ([K072121](/device/K072121.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION July 31, 2025 Zimmer Biomet Sean Gleason Regulatory Affairs Manager 1800 W Center Street Warsaw, Indiana 46580 Re: K243571 Trade/Device Name: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, KWZ Dated: July 1, 2025 Received: July 1, 2025 Dear Sean Gleason: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} K243571 - Sean Gleason Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K243571 - Sean Gleason Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Limin Sun -S Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use Submission Number (if known) K243571 Device Name Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners Indications for Use (Describe) Acetabular Liners: The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage. Constrained Liners: The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) --- **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov > "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Page 1 of 1 {4} K243571 Page 1 of 3 # 510(k) Summary Applicant: Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580, USA Establishment Registration Number: 1822565 Contact Person: Sean Gleason Regulatory Affairs Manager Telephone: 220-219-8092 Email: sean.gleason@zimmerbiomet.com Date: July 31, 2025 Subject Device: Trade Name: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners 510(k) Number: K243571 Common Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Classification Name & Product Code: JDI: Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350) KWZ: Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310) Predicate Device(s): Primary Predicate 510(k): K051516 Predicate Trade Name: Trabecular Metal Revision Shell Liners Product Code: JDI Additional Predicate 510(k): K072121 Predicate Trade Name: Trabecular Metal Acetabular Revision System Cemented Constrained Liner Product Code: KWZ Device Description Summary: The Trabecular Metal Acetabular Revision System (TMARS) Acetabular Liner and Cemented Constrained Liner are polyethylene/ metal acetabular liners, which, when used with a Trabecular Metal Acetabular Revision System Shell, forms the acetabular component of a total hip prosthesis. The acetabular liner constructs are manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The cemented constrained liners are manufactured from Longevity highly cross-linked UHMWPE and contain a titanium alloy constraining ring. All devices in the scope of this 510(k) are sterile, single-use items. {5} K243571 Page 2 of 3 ## Intended Use/Indications for Use: **Acetabular Liners:** The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage. **Constrained Liners:** The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. ## Indications for Use Comparison: The subject device has the same intended use and indications for use as the predicates. ## Technological Comparison: The technological characteristics of the subject device and predicate device are similar. The rationale for substantial equivalence is based on consideration of the following characteristics: - Intended Use: Identical to the predicate device - Indications for Use: Identical to the predicate device - Raw Materials: Identical to the predicate device - Design Features: Identical to the predicate device - Packaging: Identical to the predicate device - Sterilization: Different sterilization method, however sterility assurance level is identical to the predicate ## Non-Clinical and/or Clinical Tests Summary & Conclusions: The following non-clinical testing and assessments were performed to support substantial equivalence: - Lever Out (TMARS Constrained Liner) - Liner and Shell Torque-Out (TMARS Liner and Constrained Liner) - Dynamic Impingement (TMARS Liner and Constrained Liner) - Liner Push-Out (TMARS Liner and Constrained Liner) - Liner-Head Pull Out (TMARS Constrained Liner) - Polyethylene Liner Wear (TMARS Liner and Constrained Liner) - Range of Motion (TMARS Liner and Constrained Liner) No clinical testing was conducted. {6} K243571 Page 3 of 3 Biocompatibility testing on the TMARS Liners and Constrained Liners was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed with no unexpected results. The TMARS Liners and Constrained Liners conform to the material properties of ASTM F648. The material properties of the subject device are comparable to the predicate devices. All non-clinical testing and assessments demonstrated that the new device is substantially equivalent to the predicate device. **Substantial Equivalence Conclusion:** Based on the information provided in this submission, the Trabecular Acetabular Revision System, Acetabular Liners and Constrained Liners is substantially equivalent to the identified predicate device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K243571](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K243571) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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