Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3380](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3380) → JDH — Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

# JDH · Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

_Orthopedic · 21 CFR 888.3380 · Class 3_

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

## Overview

- **Product Code:** JDH
- **Device Name:** Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
- **Regulation:** [21 CFR 888.3380](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3380)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a recess in the head of the device. The head of the device is made of polyacetal (polyoxymethylene) and it is covered by a metallic alloy, such as cobalt-chromium-molybdenum. The trunnion bearing allows the head of the device to rotate on its stem. The prosthesis is 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/JDH](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDH)

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