← Product Code [KXA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA) · K892398

# BIPOLAR HIP SYSTEM (K892398)

_Orthomet, Inc. · KXA · May 23, 1989 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K892398

## Device Facts

- **Applicant:** Orthomet, Inc.
- **Product Code:** [KXA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA.md)
- **Decision Date:** May 23, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3400
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A hip joint femoral (hemi-hip) metallic resurfacing 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 a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K892398](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K892398)

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