Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3750](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3750) → KWN — Prosthesis, Wrist, Carpal Lunate

# KWN · Prosthesis, Wrist, Carpal Lunate

_Orthopedic · 21 CFR 888.3750 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/KWN

## Overview

- **Product Code:** KWN
- **Device Name:** Prosthesis, Wrist, Carpal Lunate
- **Regulation:** [21 CFR 888.3750](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3750)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.

## Classification Rationale

Class II.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K141920](/device/K141920.md) | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | Dec 23, 2014 | SESE |
| [K080997](/device/K080997.md) | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | Jun 17, 2008 | SESE |
| [K050028](/device/K050028.md) | MAESTRO CARPAL HEMIARTHROPLASTY | Biomet Manufacturing, Inc. | Mar 25, 2005 | SESE |
| [K864491](/device/K864491.md) | SWANSON TITANIUM CARPAL LUNATE IMPLANT | Dow Corning Wright | Apr 15, 1987 | SESE |
| [K790793](/device/K790793.md) | AMC R METACARPAL COMPONENT | Howmedica Corp. | Jun 22, 1979 | SESE |

## Top Applicants

- Arthrosurface, Inc. — 1 clearance
- Ascension Orthopedics, Inc. — 1 clearance
- Biomet Manufacturing, Inc. — 1 clearance
- Dow Corning Wright — 1 clearance
- Howmedica Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/KWN](https://fda.innolitics.com/productcode/KWN)

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