TRABECULAR METAL REVISION SHELL LINERS

K051516 · Zimmer, Inc. · JDI · Jul 27, 2005 · Orthopedic

Device Facts

• Record ID: K051516
• Device Name: TRABECULAR METAL REVISION SHELL LINERS
• Applicant: Zimmer, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jul 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trabecular Metal Revision Shell Liners are 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.

Device Story

Trabecular Metal Revision Shell Liners are acetabular cup inserts used in hip arthroplasty. Device functions as a polyethylene bearing surface within a Trabecular Metal Revision Shell. Used for initial placement or as an in situ replacement for damaged or worn components. Operated by orthopedic surgeons in a clinical/surgical setting. Provides a stable bearing surface to address joint instability, wear, or damage, facilitating hip joint function and patient mobility.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical performance testing.

Technological Characteristics

Acetabular cup insert; polyethylene bearing surface; cemented fixation; 0- and 10-degree face angle versions; various sizes to accommodate patient anatomy.

Indications for Use

Indicated for patients requiring hip joint replacement or revision, specifically for joint instability, wear, and/or damage. Intended for cemented use within the Trabecular Metal Revision Shell.

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

• Implex Hedrocel® Replacement Cup Insert (K983128)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

JUL 2 7 2005

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain<br>Manager, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | June 7, 2005 |
| Trade Name: | Trabecular Metal™ Revision Shell Liners |
| Common Name: | Acetabular Cup |
| Classification Name<br>and Reference: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,<br>Cemented<br>21 CFR § 888.3350 |
| Predicate Device: | Implex Hedrocel® Replacement Cup Insert,<br>manufactured by Zimmer TMT (formerly known as<br>Implex), K983128, cleared December 3, 1998. |
| Device Description: | This modified device is intended for cemented use<br>in conjunction with a Trabecular Metal Revision<br>Shell. The liner is offered in a broad range of sizes<br>with 0- and 10-degree face angle versions to<br>accommodate a variety of patient anatomies. |
| Intended Use: | The Trabecular Metal Revision Shell Liners are<br>indicated for cemented use in the Trabecular Metal<br>Revision Shell for initial placement or as an in situ<br>replacement polyethylene bearing surface for joint<br>instability, wear and/or damage. |
| Comparison to Predicate Device: | Except for a change in material and minor<br>dimensional changes, the Trabecular Metal<br>Revision Shell Liners are identical to the predicate<br>device. The modified device uses the same<br>operating principle, intended uses and fixation<br>method as the predicate device. |

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K051516/S1

Special 510(k): Device Modification

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2005

Ms. Karen Cain Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K051516

Trade/Device Name: Trabecular Metal™ Revision Shell Liners Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: July 14, 2005 Received: July 15, 2005

Dear Ms. Cain:

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. Karen Cain

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wifi anow you to organizal equivalence of your device of your device to a legally premarket notification: "The Pro Printings of 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 If you doon't the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

St. Kipti Church

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

Enclosure

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K 051576/51

## Indications for Use

510(k) Number (if known):

Device Name:

Trabecular Metal™ Revision Shell Liners

## Indications for Use:

The Trabecular Metal Revision Shell Liner is indicated for cemented use in the Trabecular Metal THE Travet and Mellar Revision Bhich Ement polyethylene bearing surface for joint instability, wear and/or damage.

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)

Hyt Slurdu

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

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KOS 1516 510(k) Number.