SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE

K042515 · Smith & Nephew, Inc. · JWH · Mar 14, 2005 · Orthopedic

Device Facts

• Record ID: K042515
• Device Name: SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.

Device Story

High Performance Knee is a total knee prosthesis system comprising femoral, tibial insert, and patellar components; designed for use with existing Genesis II tibial trays. System enables greater flexion range for patients with anatomical capability. Intended for surgical implantation by orthopedic surgeons in hospital settings. Device functions as a semi-constrained, cemented, polymer/metal/polymer prosthesis to replace knee joint surfaces. Benefits include restoration of joint function and increased range of motion in patients with degenerative or inflammatory joint disease. Single-use device.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by mechanical test data demonstrating the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading.

Technological Characteristics

Semi-constrained, cemented, polymer/metal/polymer knee prosthesis. Components include femoral, tibial insert, and patellar parts. Designed for use with Genesis II tibial trays. Single-use.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis requiring primary or revision total knee replacement, specifically those with absent/incompetent anterior and posterior cruciate ligaments and intact collateral ligaments. Suitable for older patients with compatible age, weight, and activity levels. Contraindicated for non-cemented use.

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

• Smith & Nephew Genesis II Knee System (K951987)
• Genesis II & Profix Zirconium Femoral Knee Components (K962557)
• Zimmer NexGen Complete Knee Solution LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581)

Submission Summary (Full Text)

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KC42515

## Smith & Nephew, Inc. Summary of Safety and Effectiveness High Performance Knee

MAR 1 : 2005

## Contact Person and Address

Date of Summary: September 15, 2004

Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: High Performance Knee Common Name: Knee prosthesis

## Device Description

The High Performance Knee consists of femoral, tibial insert and patellar components to be used with existing Genesis II tibial trays. The High Performance Knee is a total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range.

#### Device Classification

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

#### Mechanical and Clinical Data

A review of the mechanical test data indicated that the High Performance Knee is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.

## Indications for Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.

#### Substantial Equivalence Information

The substantial equivalence of the High Performance Knee is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices -- Smith & Nephew Genesis II Knee System and Genesis II & Profix Zirconium Femoral Knee Components (K951987 and K962557, respectively) and the Zimmer NexGen Complete Knee Solution LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581).

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Image /page/1/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its wings and a wavy line representing its body. The bird is enclosed within a circular border. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top and bottom of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR I 스 2005

Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K042515

Trade/Device Name: High Performance Knee Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis

Regulatory Class: II Product Codes: JWH Dated: March 1, 2005 Received: March 2, 2005

Dear Ms. Akil:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(t) promotion is substantially equivalent (for the indications felerenced above and nave determined be and marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1970, the encordance with the provisions of the Federal Food. Drug, devices that have occh recatissimed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvince of the general controls provisions of the Act. The Tou may, mercetore, market the do received been contrements for annual registration, listing of general controls provisions of aactice, 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 n your device is classified (boo abor of this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations Inay be subject to suen additional seculations, Title 21, Parts 800 to 898. In addition, FDA may ou round in the overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that 1 Dr 3 issuanted or a subside complies with other requirements of the Act that I DA has made a acterimialisions administered by other Federal agencies. You must of any I catal statutes and regulations and admited to: registration and listing (21

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# Page 2 – Ms. Janet Johnson Akil

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as services also a CFR Part 807), fabeing (21 CFR Part 800); and if applicable, the clectronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manening your and equivalence of your device to a legally premarket notheadon. The IDA miding of Sassamal repair 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 advice for your acc [phone]. Also, please note the regulation entitled, Colliact the Office of Comphanes at (210) 21 (21CFR Part 807.97). You may obtain Wilsoranding by reference to premainsmonitibilities under the Act from the Division of Small biller geleral information on Jour response Assistance at its toll-free number [phone] or Manufacturers, International and Octisal http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark A. Millman

Miriam Provost, Ph.D. Acting 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): | K042515 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: High Performance Knee

Indications for Use:

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, Total knee components are mated for mean assessments whose age, weight, and activity level are osteoarminis, or degeneralite in elast particles, unicompartmental replacement, compatible with an docquate tong term stabilized knee systems are designed for use in patients in or total knee replacement. Tootener the anterior and posterior cruciate ligaments are absent or phitrially and revision surger); whole ints remain intact. Smith & Nephew, Inc. High Performance incompetent and the sondicated for use only with cement and are single use devices.

Prescription Use × (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)

(Division Sign-Off)
Division of General, Rectorative,
and Neurological Devic...s

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510(k) Number- K042515