← Product Code [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ) · P960047

# OSTEONICS CONSTRAINED ACETABULAR INSERT (P960047)

_Howmedica Osteonics Corp. · KWZ · Jun 13, 1997 · Orthopedic · APRL_

**Canonical URL:** https://fda.innolitics.com/submissions/ORTHOPEDIC/subpart-d%E2%80%94prosthetic-devices/KWZ/P960047

## Device Facts

- **Applicant:** Howmedica Osteonics Corp.
- **Product Code:** [KWZ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWZ.md)
- **Decision Date:** Jun 13, 1997
- **Decision:** APRL
- **Regulation:** 21 CFR 888.3310
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

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**Source:** [https://fda.innolitics.com/submissions/ORTHOPEDIC/subpart-d%E2%80%94prosthetic-devices/KWZ/P960047](https://fda.innolitics.com/submissions/ORTHOPEDIC/subpart-d%E2%80%94prosthetic-devices/KWZ/P960047)

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