← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K964008

# FOUNDATION KNEE SYSTEM (K964008)

_Encore Orthopedics, Inc. · JWH · Dec 27, 1996 · Orthopedic · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K964008

## Device Facts

- **Applicant:** Encore Orthopedics, Inc.
- **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md)
- **Decision Date:** Dec 27, 1996
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3560
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The indications for use of this femoral insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.

## Device Story

Femoral component for knee arthroplasty; articulates with Foundation® Knee System. Six sizes available. CoCr alloy (ASTM F75) base; plasma-sprayed commercially pure titanium surface for fixation; two smooth pegs for medial/lateral stability. Used by orthopedic surgeons in clinical/OR settings to replace damaged femoral condyles. Restores joint articulation and stability; addresses degenerative/traumatic joint conditions.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Material: CoCr alloy (ASTM F75) with plasma-sprayed commercially pure titanium coating. Design: Six sizes; two smooth pegs for stability. Semiconstrained cemented prosthesis.

## Regulatory 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

- Foundation® Primary Knee System ([K923277](/device/K923277.md))
- Biomet Maxim® Knee System

## Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

Encore Orthopedics®, Inc.
8900 Shoal Creek BLVD.
Suite 300
Austin, TX 78757
512-206-1437
Ashley M. Bock

*K924008*

DEC 27 1996

**Trade Name:** Femoral Component

**Common Name:** Femoral Component

**Classification Name:** Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.

**Description:** This femoral component is available in six sizes, to fit into, and articulate with, the existing Foundation® Knee System. The CoCr alloy (ASTM F75) component is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance fixation. The femoral component has two smooth pegs to provide medial/lateral stability.

**Indications:** The indications for use of this femoral insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.

**Comparable Features to Predicate Device(s):** This device is similar in features, design and indications as the Foundation® Primary Knee System (K923277) and Biomet Maxim® Knee System.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K964008](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K964008)

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