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) → KWM — Prosthesis, Wrist, Semi-Constrained

# KWM · Prosthesis, Wrist, Semi-Constrained

_Orthopedic · 21 CFR 888.3800 · Class 2_

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

## Overview

- **Product Code:** KWM
- **Device Name:** Prosthesis, Wrist, 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K880156](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K880156.md) | VOLZ TOTAL WRIST PROSTHESIS | Biomet, Inc. | Feb 17, 1988 | SESE |
| [K872502](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K872502.md) | M.W.P. WRIST PROSTHESIS | Protek, Inc. | Jul 23, 1987 | SESE |
| [K803031](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K803031.md) | LAURE WRIST IMPLANT | Laure Prosthetics, Inc. | Jun 29, 1982 | SESE |
| [K800602](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K800602.md) | TALEISNIK TOTAL WRIST PROSTHESIS | Dow Corning Wright | Aug 27, 1980 | SESE |
| [K801157](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K801157.md) | WEBER-MAYO WRIST | Depuy, Inc. | Aug 4, 1980 | SESE |
| [K790774](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWM/K790774.md) | LODA WRIST PROSTHESIS | Depuy, Inc. | Aug 3, 1979 | SESE |

## Top Applicants

- Depuy, Inc. — 2 clearances
- Biomet, Inc. — 1 clearance
- Dow Corning Wright — 1 clearance
- Laure Prosthetics, Inc. — 1 clearance
- Protek, Inc. — 1 clearance

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

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