Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

K243571 · Zimmer Biomet · JDI · Jul 31, 2025 · Orthopedic

Device Facts

• Record ID: K243571
• Device Name: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
• Applicant: Zimmer Biomet
• Product Code: JDI · Orthopedic
• Decision Date: Jul 31, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• 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.

Indications for Use

Indicated for complex primary or revision hip arthroplasty patients at high risk of dislocation (history of dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability) where other constrained options are unsuitable; also indicated for initial placement or in situ replacement of polyethylene bearing surfaces in the Trabecular Metal Revision Shell for joint instability, wear, or damage.

Regulatory Classification

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)
• Trabecular Metal Acetabular Revision System Cemented Constrained Liner (K072121)

Submission Summary (Full Text)

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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.

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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-

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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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)

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# 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: [phone]
Email: [e-mail]

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.

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## 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.

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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.