DEPUY SIGMA TIBIAL INSERTS

K033272 · DePuy Orthopaedics, Inc. · JWH · Feb 5, 2004 · Orthopedic

Device Facts

• Record ID: K033272
• Device Name: DEPUY SIGMA TIBIAL INSERTS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sigma Tibial Inserts 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.

Device Story

DePuy Sigma Tibial Inserts are posterior lipped, cruciate retaining or stabilized UHMWPE components for total knee replacement. Device functions as an articular surface within a knee prosthesis system. Designed for use with Sigma Co-Cr Tibial Trays and Darwin femoral components. Modifications from predicate include larger distal mating surface for tighter fit with trays and updated locking mechanism to reduce micromotion between insert and tray. Used by orthopedic surgeons in clinical settings during total knee arthroplasty. Provides stable articulation to restore joint function, reduce pain, and improve mobility for patients with severe structural knee damage.

Technological Characteristics

Material: UHMWPE. Design: Posterior lipped, cruciate retaining or stabilized tibial insert. Features: Larger distal mating surface and modified locking mechanism for integration with Sigma Co-Cr Tibial Trays. Semi-constrained cemented prosthesis.

Indications for Use

Indicated for patients requiring total knee replacement due to severe pain and disability from structural damage caused by rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma, or failed prior surgical intervention.

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)
• Darwin Knee System (K950010)
• Darwin Knee System (K961685)
• Darwin Knee System (K971189)

Reference Devices

• Sigma Co-Cr Tibial Trays (K032151)

Submission Summary (Full Text)

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FEB - 5 2004

K033272

## 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 Tibial Inserts |
| 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>DEVICES: | Johnson & Johnson Professional, Inc. (now<br>DePuy) Darwin Knee System - K943462, K950010,<br>K961685, K971189 |

#### DEVICE DESCRIPTION:

The DePuy Sigma Tibial Inserts are posterior lipped, cruciate retaining or stabilized UHMWPE tibial inserts with the same articular surface and basic geometry as the tibial inserts cleared in K943462, K950010, K961685 and K971189. Compared to the predicate inserts, the Sigma inserts have a larger distal mating surface to provide a tighter fit with the Sigma Tibial Trays. The locking mechanism has also been modified to reduce micromotion between the tibial insert and the tibial tray components. The Sigma Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.

### INTENDED USE AND INDICATIONS:

The Sigma Tibial Inserts 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.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The Sigma Tibial Inserts have the same basic design and the same intended use as the tibial inserts of the Darwin Knee System. Minor design modifications have been made to the tibial inserts to provide a tighter fit with the Sigma Co-Cr Tibial Trays. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the Sigma Tibial Inserts are substantially equivalent to the previously cleared tibial inserts of the Darwin Knee System.

Dage 1 of 1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

Ms. Cheryl Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 45681-0988

Re: K033272

Trade/Device Name: DePuy Sigma Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: January 16, 2004 Received: January 20, 2004

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. Ilisting 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 I'DA'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. Cheryl Hastings

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 yours,

Sincerely yours,

Mark A. Millican

Celia M. Witten, Ph.D., M.D. Division 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

510(k) Number (if known): ___K033272 _________________________________________________________________________________________________________________________________________

Device Name: __ DePuy Sigma Tibial Inserts

Indications for Use:

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

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. Mark N. Milburn

r of General, Restorative art102ical Devices

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K05327d

(Posted November 13, 2003)