← Product Code [JWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWI) · K931265

# FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND (K931265)

_Ferguson Medical · JWI · May 22, 1995 · Orthopedic · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWI/K931265

## Device Facts

- **Applicant:** Ferguson Medical
- **Product Code:** [JWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWI.md)
- **Decision Date:** May 22, 1995
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3800
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist 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 have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) 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/JWI/K931265](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWI/K931265)

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