The Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS 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 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 Description

The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trabecular Metal Acctabular Revision Shell (K050937, cleared May 11, 2005), forms the acetabular component of a total bip prosthesis. The device consists of a Longewire highly crosslinked polyethylene liner and a Tivanium " Titanium alloy constraming ring. The liner allows for mechanical capture of the metal fernoral head and greater flexion/extension range of motion than hooded constrained liner designs. Subject acetabular liners are available in mner diameters of 28. 32 and 36mm.

AI/ML Overview

The provided text describes a medical device submission (K072121) for the Trabecular Metal™ Acetabular Revision System Cemented Constrained Liner.

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than setting new, specific performance-based acceptance criteria for a novel device. Therefore, the "acceptance criteria" are implied by the demonstration of substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence to Predicate Device	Mechanical Testing of the modified device indicates that it is substantially equivalent to the predicate.
Material Composition	The device consists of a Longevity® highly crosslinked polyethylene liner and a Tivanium™ Titanium alloy constraining ring. (This matches the general material types of predicate devices in this category).
Intended Use	For use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation... (Matches the general indications of constrained acetabular liners).
Dimensional Compatibility	Available in inner diameters of 28, 32, and 36mm. (Matches sizing of common hip prostheses, including predicate devices).

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device."
Therefore, there was no test set of clinical data (images, patient outcomes, etc.) used. The evaluation was based on non-clinical (mechanical) testing.
Data Provenance: Not applicable, as no clinical data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done, as this is a physical medical device (an acetabular liner) and not an AI-based diagnostic or assistive technology.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical mechanical testing, the "ground truth" would be established by engineering standards and specifications for mechanical properties (e.g., strength, wear resistance, range of motion). The mechanical testing would assess if the device meets these pre-defined engineering performance targets and compares favorably to the established performance of the predicate device under similar testing conditions.

8. The Sample Size for the Training Set

Not applicable, as no AI/machine learning model was being trained. The "training set" concept does not apply to the mechanical testing of this physical device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there was no training set for an AI/machine learning model. For mechanical testing, the equivalent would be the established engineering specifications and the performance characteristics of the predicate devices.

Summary

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K072121

Summary of Safety and Effectiveness

Submitter:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Names and References:

Predicate Device:

Device Description:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

JAN - 7 2008

Patricia Jenks Specialist, Corporate Regulatory Affairs Telephone: (574) 371-8354 Fax: (574) 372-4605

October 11. 2007

Trabecular MetaltM Acetabular Revision System Cemented Constrained Liner

Constramed Acctabular Liner

21 CFR 888,3310: Hip joint metal | polymer constrained cemented or uncemented prosithesis, Product code: 87 KWZ

Trilogy" Longevity * Constrained Liner, K071718, cleared July 13, 2007 and Trabecular Metal Revision Shell Liners, K051516, cleared July 27, 2005

The liner allows for mechanical capture of the metal fernoral head and greater flexion/extension range of motion than hooded constrained liner designs.

and the comments of the country of the

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diameters of 28. 32 and 36mm. The Trabecular Metal Acetabular Revision System Intended Use: (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS shell, the shell is intended for comentless 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 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 acctabular components have been considered. Comparison to Predicate Device: Two predicates form the design of the Trahecular Metal Acetabular Revision System Cemented Constrained Liner. The from side/femoral head capture region exactly matches the Trilogy Longevity Constrained Liner and the backside has been modified with cement interdigitation grooves to allow for cement fixation into a Trabecular Metal Acetabular Revision Shell, exactly matching the backside of the Trabecular Metal Revision Shell Liners. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or (Clinical): Mechanical Testing of the modified device indicates that it is substantially equivalent to the predicate. Clinical Performance and Conclusions: Clinical data and conclusions were not needed

for this device.

the submit the submit and the submit of the subject of

Subject acetabular liners are available in mner

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping, curved lines that resemble a stylized human figure or a bird in flight. The overall design is simple and recognizable, representing the department's mission and identity.

Public Health Service

JAN - 7 2008

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Zimmer. Inc. c/o Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, IN 46581-0708

Re: K072121

Trade/Device Name: Trabecular Metal™ Acetabular Revision System Cemented Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: December 20, 2007 Received: December 26, 2007

Dear Ms. Jenks:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Patricia Jenks

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

4072121 510(k) Number (if known):

Device Name:

Trabecular Metal Metabular Revision System Cemented Constrained Liner

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hauuuu V. Ougue FOR M.MELKERSON

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K072121

025

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”