GENESIS II CONSTRAINED SYSTEM

K962137 · Smith & Nephew Richards, Inc. · JWH · Aug 2, 1996 · Orthopedic

Device Facts

• Record ID: K962137
• Device Name: GENESIS II CONSTRAINED SYSTEM
• Applicant: Smith & Nephew Richards, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesis II Constrained System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The Genesis II Constrained System is designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. The Genesis II Constrained System is indicated for use with cement and is a single use device.

Device Story

Genesis II Constrained System; knee arthroplasty implant. Components: cobalt-chromium-molybdenum femoral component; ultra-high-molecular-weight polyethylene tibial insert. Design: box-like femoral component mates with tibial post to constrain motion. Used in primary and revision knee surgery; indicated for patients with ligamentous instability (absent/incompetent posterior cruciate and collateral ligaments). Implanted by orthopedic surgeons in hospital/OR setting. Provides mechanical stability to knee joint; replaces damaged articular surfaces; restores joint function. Single-use; requires bone cement.

Clinical Evidence

Bench testing only. Mechanical testing performed per knee draft guidance document; results indicate capability to withstand in vivo loading without failure.

Technological Characteristics

Materials: cobalt-chromium-molybdenum (femoral component), ultra-high-molecular-weight polyethylene (tibial insert). Design: constrained knee system with box-like femoral component and tibial post. Single-use; requires bone cement fixation.

Indications for Use

Indicated for patients with rheumatoid, post-traumatic, osteoarthritis, or degenerative arthritis, or failed prior knee surgeries (osteotomies, unicompartmental, or total knee replacement). Specifically for primary or revision surgery where posterior cruciate and one or both collateral ligaments are absent or incompetent. For use with cement; single-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

• Genesis Constrained Knee System (Smith & Nephew Richards)
• Genesis II Knee System (Smith & Nephew Richards)
• Genesis I P/S Knee Systems (Smith & Nephew Richards)
• Insall/Burstein Constrained Condylar Knee (Zimmer)
• P.F.C. Modular Knee System (Johnson & Johnson)
• Omnifit Total Knee System (Osteonics)
• Coordinate Revision Knee System (Depuy)

Submission Summary (Full Text)

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K962137

AUG - 2 1996

# Summary of Safety and Effectiveness
Smith & Nephew Richards Inc.
Genesis II Constrained System

## Substantial Equivalence Information

The Genesis II Constrained System is similar to the following knee systems

1. Genesis Constrained Knee System - Smith & Nephew Richards
2. Genesis II Knee System - Smith & Nephew Richards
3. Genesis I P/S Knee Systems - Smith & Nephew Richards
4. Insall/Burstein Constrained Condylar Knee - Zimmer
5. P.F.C. Modular Knee System - Johnson & Johnson
6. Omnifit Total Knee System - Osteonics
7. Coordinate Revision Knee System - Depuy

All of the devices listed above are similar in design to the Genesis II Constrained System. The safety and effectiveness of the Genesis II Constrained System is based on the long history of use of these devices in the market place.

## Device Description

The Genesis II Constrained System consists of a femoral component and a tibial insert. The femoral component is manufactured from cobalt-chromium-molybdenum and the tibial insert is manufactured from ultra-high-molecular-weight polyethylene. The femoral component has a box-like design that mates with a post on the tibial insert to constrain motion.

## Indications for Use

The Genesis II Constrained System is indicated for:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The Genesis II Constrained System is designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Genesis II Constrained System is indicated for use with cement and is a single use device.

## Mechanical Testing

Mechanical testing was performed according to the requirements in the knee draft guidance document. All of the test results indicate that the Genesis II Constrained System is capable of withstanding *in vivo* loading without failure.

G205086D