Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3350](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3350) → OQH — Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

# OQH · Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

_Orthopedic · 21 CFR 888.3350 · Class 2_

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

## Overview

- **Product Code:** OQH
- **Device Name:** Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
- **Regulation:** [21 CFR 888.3350](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3350)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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