GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT

K962557 · Smith & Nephew Richards, Inc. · JWH · Dec 5, 1996 · Orthopedic

Device Facts

• Record ID: K962557
• Device Name: GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
• Applicant: Smith & Nephew Richards, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 5, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Genesis II and Profix Knee Systems are 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. Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.

Device Story

Genesis II and Profix Zirconium Femoral Components; cruciate retaining knee implants. Manufactured from zirconium alloy; designed for use with existing Genesis II and Profix system components. Used in total knee arthroplasty; implanted by orthopedic surgeons in clinical/OR settings. Provides structural replacement for femoral joint surfaces; intended for cemented fixation. Benefits include material properties of zirconium alloy for durability in patients requiring joint replacement.

Clinical Evidence

Bench testing only. Mechanical testing performed per knee draft guidance; material characterization conducted. Results indicate components withstand in vivo loading without failure.

Technological Characteristics

Zirconium alloy femoral components; cruciate retaining design. Available in multiple sizes, left/right orientations. Designed for cemented use only. Single-use device.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, and those with failed osteotomies, unicompartmental replacement, or total knee replacement. Intended 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).

Reference Devices

• Genesis II C/R and LDK Femoral Component
• Profix C/R Femoral Component
• Genesis I C/R Femoral Component
• Zirconium Alloy Femoral Head
• Zirconium Alloy Uni-Polar Head

Submission Summary (Full Text)

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DEC - 5 1996
K96 2557

# Summary of Safety and Effectiveness
## Smith & Nephew Orthopaedics
## Genesis II Zirconium Femoral Component
## Profix Zirconium Femoral Component

## Substantial Equivalent Information

The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are similar to the devices listed below.

1. Genesis II C/R and LDK Femoral Component
2. Profix C/R Femoral Component
3. Genesis I C/R Femoral Component

The devices listed above are similar in design to the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component. The zirconium alloy material used to manufacture the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component is the same material used for both the Zirconium Alloy Femoral Head and the Zirconium Alloy Uni-Polar Head.

## Device Description

The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are cruciate retaining components indicated for use with existing Genesis II and Profix System Components. Both are manufactured in a variety of sizes in both left and right orientations.

## Indications for Use

Genesis II and Profix Knee Systems are 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.

Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.

## Preclinical Testing

Mechanical testing was performed according to the requirements in the knee draft guidance document. Testing was also performed to characterize the material properties. All of the test results indicate that both the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are capable of withstanding *in vivo* loading without failure.

JG06246B/19