DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS

K032151 · Depuy, Inc. · JWH · Sep 26, 2003 · Orthopedic

Device Facts

• Record ID: K032151
• Device Name: DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
• Applicant: Depuy, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sigma Co-Cr Tibial Trays are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The Sigma Co-Cr Tibial Trays are intended for cemented use only.

Device Story

The DePuy Sigma Co-Cr Tibial Tray is a prosthetic component for total knee replacement surgery. It serves as the tibial baseplate in a semi-constrained cemented knee system. The device is designed to interface with previously cleared PFC Sigma femoral and patella components. It is intended for use by orthopedic surgeons in a clinical/surgical setting. The tray provides a stable platform for the knee joint, aiming to restore function and alleviate pain caused by structural damage from arthritis or trauma. The device is implanted via surgical procedure using bone cement.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and manufacturing similarities to the predicate device.

Technological Characteristics

Material: Forged Co-Cr-Mo alloy. Design: Tibial tray for semi-constrained cemented total knee arthroplasty. Compatibility: Designed for use with PFC Sigma femoral and patella components. Energy source: None (passive implant).

Indications for Use

Indicated for patients requiring total knee replacement due to severe pain and disability from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma, or failed prior surgery. Intended for cemented use only.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Darwin Knee System (K943462)

Submission Summary (Full Text)

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032151

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## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings<br>Director, Regulatory Affairs |
| TRADE NAME: | DePuy Sigma Co-Cr Tibial Trays |
| COMMON NAME: | Total Knee Joint Replacement Prosthesis |
| CLASSIFICATION: | 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis; Class II |
| DEVICE PRODUCT CODE: | 87 JWH |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | Johnson & Johnson Professional, Inc. (now DePuy)<br>Darwin Knee System - K943462 |

### DEVICE DESCRIPTION:

The DePuy Sigma Co-Cr Tibial Trays are Co-Cr-Mo alloy tibial trays similar in design to the Darwin tibial trays cleared in K943462. The Sigma Co-Cr Tibial Trays are intended for use with the Darwin (now PFC Sigma) femoral and patella components, previously cleared in K943462.

#### INTENDED USE AND INDICATIONS:

The Sigma Co-Cr Tibial Trays are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The Sigma Co-Cr Tibial Trays are intended for cemented use only.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Sigma Co-Cr Tibial Trays have the same basic design and the same intended use as the tibial trays of the Darwin Knee System. Like the Darwin trays, the Sigma Co-Cr trays can be used with the existing PFC Sigma femoral and patella components. The tibial tray material has been changed from forged Ti-6Al-4V alloy to forged Co-Cr-Mo alloy. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the Sigma Co-Cr Tibial Trays are substantially equivalent to the previously cleared trays of the Darwin Knee System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

SEP 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw. Indiana 46581-0988

Re: K032151

Trade/Device Name: DePuy Sigma Co-Cr Tibial Trays Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: August 27, 2003 Received: August 28, 2003

Dear Ms. Hastings:

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. Iisting 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 (OS) 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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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 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 Manufacturers, International 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 vours,

Sincerely yours,

Mark N Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications Statement

510(k) Number (if known) k032151

Device Name DePuy Sigma Co-Cr Tibial Trays

Intended Use and Indications:

The Sigma Co-Cr Tibial Trays are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The Sigma Co-Cr Tibial Trays are intended for cemented use only.

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Concurrence of CDRH, Office of Device Evaluation

for Mark N. Millican

Tivision Sign-Off) Latision of General, Restorative and Neurological Devices Kossalis

510(k) Number_

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The Counter Use