← Product Code [KXE](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE) · K010786

# ULNAR HEAD IMPLANT (K010786)

_Avanta Orthopaedics, Inc. · KXE · Apr 11, 2001 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K010786

## Device Facts

- **Applicant:** Avanta Orthopaedics, Inc.
- **Product Code:** [KXE](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE.md)
- **Decision Date:** Apr 11, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 888.3810
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K010786](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K010786)

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