← Product Code [KYK](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK) · K880826

# MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM (K880826)

_Johnson & Johnson Professionals, Inc. · KYK · Mar 14, 1988 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK/K880826

## Device Facts

- **Applicant:** Johnson & Johnson Professionals, Inc.
- **Product Code:** [KYK](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK.md)
- **Decision Date:** Mar 14, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3500
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of 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 with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement (§ 888.3027).

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK/K880826](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYK/K880826)

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