Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3370](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3370) → KWB — Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

# KWB · Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

_Orthopedic · 21 CFR 888.3370 · Class 3_

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

## Overview

- **Product Code:** KWB
- **Device Name:** Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
- **Regulation:** [21 CFR 888.3370](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3370)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have an acetabular component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Classification Rationale

Class III.

## 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/KWB](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWB)

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