← Product Code [JDL](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL) · K930833

# PCA(R) SOLID BACK ACETABULA SHELL (K930833)

_Howmedica Corp. · JDL · Feb 22, 1994 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K930833

## Device Facts

- **Applicant:** Howmedica Corp.
- **Product Code:** [JDL](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL.md)
- **Decision Date:** Feb 22, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3320
- **Device Class:** Class 3
- **Review Panel:** Orthopedic

## Regulatory Identification

A hip joint metal/metal semi-constrained, with a cemented acetabular component, 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 and an acetabular component, both 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).

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K930833](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDL/K930833)

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