Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3800](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3800) → JWI — Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained

# JWI · Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained

_Orthopedic · 21 CFR 888.3800 · Class 2_

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

## Overview

- **Product Code:** JWI
- **Device Name:** Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
- **Regulation:** [21 CFR 888.3800](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3800)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## 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).

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K931265](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWI/K931265.md) | FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND | Ferguson Medical | May 22, 1995 | SN |
| [K940297](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWI/K940297.md) | UNIVERSAL WRIST | Turnkey Intergration USA, Inc. | Feb 6, 1995 | SN |
| [K792687](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWI/K792687.md) | ASPERGILLUS SP., ANTIGEN | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |

## Top Applicants

- Ferguson Medical — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
- Turnkey Intergration USA, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com