Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3340](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3340) → KMC — Prosthesis, Hip, Semi-Constrained,  Composite/Metal

# KMC · Prosthesis, Hip, Semi-Constrained,  Composite/Metal

_Orthopedic · 21 CFR 888.3340 · Class 2_

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

## Overview

- **Product Code:** KMC
- **Device Name:** Prosthesis, Hip, Semi-Constrained,  Composite/Metal
- **Regulation:** [21 CFR 888.3340](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3340)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high molecular weight polyethylene with carbon fibers composite. Both components are intended for use with bone cement (§ 888.3027).

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K936044](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KMC/K936044.md) | ENHANCED MODULAR AUSTIN MOORE HIP | Zimmer, Inc. | Apr 26, 1994 | SESE |
| [K853524](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KMC/K853524.md) | APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT | Intermedics Orthopedics | Nov 22, 1985 | SN |
| [K853259](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KMC/K853259.md) | MALLORY/HEAD TOTAL HIP SYSTEM | Biomet, Inc. | Nov 1, 1985 | SN |

## Top Applicants

- Biomet, Inc. — 1 clearance
- Intermedics Orthopedics — 1 clearance
- Zimmer, Inc. — 1 clearance

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

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