DEPUY SIGMA XLK TIBIAL INSERTS

K040166 · DePuy Orthopaedics, Inc. · JWH · Feb 23, 2004 · Orthopedic

Device Facts

• Record ID: K040166
• Device Name: DEPUY SIGMA XLK TIBIAL INSERTS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sigma XLK 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 XLK Tibial Inserts are posterior-lipped, cruciate-retaining or stabilized components for total knee arthroplasty. Manufactured from XLK crosslinked polyethylene; designed for use with Sigma Co-Cr tibial trays and Darwin femoral components. Device functions as a bearing surface in knee replacement surgery. Used by orthopedic surgeons in clinical/hospital settings. In-vitro knee simulator testing (5 million cycles) demonstrated 89% reduction in gravimetric wear compared to predicate Darwin inserts. Clinical benefit derived from improved wear characteristics of crosslinked polyethylene material.

Clinical Evidence

Bench testing only. 5 million cycle knee simulator wear study compared Size 3 Sigma XLK inserts (n=3) against Darwin inserts (n=6). Results showed 89% less gravimetric wear for Sigma XLK. Note: In-vitro wear test results have not been shown to correlate with clinical wear mechanisms.

Technological Characteristics

Material: XLK crosslinked polyethylene. Design: Posterior-lipped, cruciate-retaining or stabilized tibial insert. Sterilization: Gas plasma. Compatible with Sigma Co-Cr tibial trays and Darwin femoral components.

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 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

• DePuy Sigma Tibial Inserts (K033272)
• 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 2 3 2004

## KO4066

### 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 XLK Tibial Inserts |
| COMMON NAME: | Total Knee Joint Replacement Prosthesis |
| CLASSIFICATION: | 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained<br>cemented prosthesis; Class II |
| DEVICE PRODUCT CODE: | 87 JWI1 |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy Sigma Tibial Inserts - K033272<br>Johnson & Johnson (now DePuy) Darwin Knee<br>System - K943462, K950010, K961685,<br>K971189 |

#### DEVICE DESCRIPTION:

The DePuy Sigma XLK Tibial Inserts are posterior lipped, cruciate retaining or stabilized tibial inserts with the same design and intended use as the tibial inserts cleared in K033272. The subject inserts are manufactured from XLK Crossfinked Polycthylene. The Sigma XLK 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.

When tested with DePuy Sigma Co-Cr Tibial Trays, the DePuy XLK Sigma Tibial Inserts exhibit 89% less gravimetric wear than previously cleared Johnson & Johnson Darwin tibial inserts tested with Johnson & Johnson PFC tibial trays. This claim is supported by 5 million cycle knee simulator wear data. The products tested were Size 3 Sigma Co-Cr Tibial Trays mated with Size 3, 10mm cruciate retaining Sigma XLK Tibial Inserts (n= 3) compared to Size 3 PFC Titanium Trays mated with Size 3, 10mm cruciate retaining Darwin (PFC Sigma) Tibial Inserts (n= 6). Both sets of inserts were articulated against Size 3 cast Co-Cr PFC Sigma cruciate retaining, non-porous coated femoral components. All tibial trays and femoral components were sterilized using ganma irradiation. The Sigma XLK inserts were sterilized using gas plasma sterilization. The Darwin Tibiah Inserts were sterilized using gamma vacuum foil (GVF) sterilization and packaging. Testing was conducted on a AMTI multi-axial displacement controlled knee joint simulator using bovine serum as a lubricant.

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Koholl

The results of in-vitro wear tests have not been shown to correlate with clinical wear mechanisms.

#### INTENDED USE AND INDICATIONS:

The Sigma XLK 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 XLK Tibial Inserts have the same design and intended use as the Sigma Inserts cleared in K033272. Mechanical testing shows that the Sigma XLK Tibial Inserts perform similarly to the Sigma and Darwin Inserts but exhibit less wear in knee simulator testing. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the Sigma Tibial XLK Inserts are substantially equivalent to the previously cleared Sigma and Darwin Tibial Inserts.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2004

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

Re: K040166

Trade/Device Name: DePuy Sigma XLK Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knce joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 24, 2004 Received: January 26, 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, 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. Cheryl K. Hastings

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manag 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 If you desire specific at not 101 your 201) 594-4659. Also, please note the regulation entitled, contact the Orited of Computers and (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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

Mark A. Millikan

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 for Use

510(k) Number (if known): K040166__________________________________________________________________________________________________________________________________________

Device Name: __DePuy Sigma XLK Tibial Inserts

Indications for Use:

Prescription Use

The Sigma XLK 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.

| Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|----------------------------------------------|--------|---------------------------------------------|
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

for Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K040166 |
|---------------|---------|
|---------------|---------|

(Posted November 13, 2003)

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Over-The-Counter Use ________