TOTAL KNEE FEMORAL COMPONENT

K022010 · Smith & Nephew, Inc. · JWH · Aug 19, 2002 · Orthopedic

Device Facts

• Record ID: K022010
• Device Name: TOTAL KNEE FEMORAL COMPONENT
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic arthritis; degenerative arthritis; failed osteotomies; hemiarthroplasties, unicompartmental replacement; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.

Device Story

Total Knee Femoral Components are metal alloy orthopedic implants processed via proprietary oxidation; designed for use with Genesis II or Profix Total Knee System tibial and patellar components. Intended for cemented implantation in patients requiring knee arthroplasty. Device provides structural replacement for damaged knee joint surfaces. Marketing claims include 85% reduction in aggregate wear rate compared to cobalt chrome components, based on multi-axial knee joint simulator testing. Used by orthopedic surgeons in clinical settings for total knee replacement procedures.

Clinical Evidence

Bench testing only. Multi-axial knee joint simulator testing performed for a minimum of 6 million cycles using size 5 Genesis II femoral components and UHMWPE tibial inserts. Results demonstrated an 85% reduction in aggregate wear rate compared to cobalt chrome femoral components (0.69 ± 0.52 mm³/million cycles vs. 4.68 ± 2.30 mm³/million cycles). Note: In vitro test results have not been shown to correlate with clinical wear mechanisms.

Technological Characteristics

Metal alloy femoral components processed via proprietary oxidation. Designed for cemented fixation. Compatible with Genesis II and Profix system components. Single-use device.

Indications for Use

Indicated for patients with rheumatoid arthritis, posttraumatic arthritis, degenerative arthritis, failed osteotomies, hemiarthroplasties, unicompartmental replacement, or total knee arthroplasties requiring cemented knee joint replacement.

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

• Genesis II Total Knee System
• Profix Total Knee System

Submission Summary (Full Text)

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# AUG 1 9 2002

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## Summary of Safety and Effectiveness Smith & Nephew, Inc. Total Knee Femoral Component

#### Contact Person and Address

Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 [phone]

#### Device Description

The Total Knee Femoral Components are designed for use with tibial and patellar components of the Genesis II or Profix Total Knee Systems. The Total Knee Femoral Components are metal alloy devices processed via a proprietary oxidation process.

#### Device Classification Name

21 CFR 888.3560 Knee joint patellofemorotibial metal/polymer/metal semi-constrained cemented prosthesis - Class II

#### Indications for Use

The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic arthritis; degenerative arthritis; failed osteotomies; hemiarthroplasties, unicompartmental replacement; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.

#### Mechanical and Clinical Data

A review of the mechanical test data indicated that the Total Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

#### Wear Claims

The following marketing claim will be made for the Total Knee Femoral Components:

- " {Total Knee Femoral Components} offer an 85% reduction in aggregate wear rate as compared to cobalt chrome (CoCr) femoral components (0.69 + 0.52 mm3/million cycles vs. 4.68 ± 2.30 mm /million cycles). Testing was performed in a multi-axial knee joint simulator for a minimum of 6 million cycles per individual test using size 5 Genesis II femoral components as an articulating counterface, size 5 Genesis II UHMWPE tibial inserts, and Hyclone bovine calf serum as a lubricant. UHMWPE tibial inserts were sterilized via ethylene oxide. For each test condition the aggregate wear rates were computed as the slope of the line fit through the averaged data (n=3) after the initial

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wear-in period of 1.94 million cycles (1.e., 1.94 -- 6.13 million cycles). The results of invitro tests have not been shown to correlate with clinical wear mechanisms."

## Substantial Equivalence Information

The substantial equivalence of the Total Knee Femoral Components is substantiated by its similarities in design features, overall indications, and material composition as existing components of the Genesis II and Profix Total Knee Systems distributed by Smith & Nephew, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim P. Kelly, M.S. Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K022010 Trade/Device Name: Total Knee Femoral Components 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: July 22, 2002 Received: July 23, 20002

Dear Ms. Kelly:

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.

AUG 1 9 2002

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Page 2 - Ms. Kim P. Kelly

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 A. Melkus

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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# Total Knee Femoral Components Indications Statement

The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic athritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.

Mark N. Millhiser

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

KO22010 510(k) Number _

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Prescription Use

OR (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________