← Product Code [HSX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX) · K792240

# POLYCENTRIC TOTAL KNEE METAL TIBIAL (K792240)

_Howmedica Corp. · HSX · Dec 5, 1979 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K792240

## Device Facts

- **Applicant:** Howmedica Corp.
- **Product Code:** [HSX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX.md)
- **Decision Date:** Dec 5, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3520
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are 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/HSX/K792240](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K792240)

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