Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3760](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3760) → KWO — Prosthesis, Wrist, Carpal Scaphoid

# KWO · Prosthesis, Wrist, Carpal Scaphoid

_Orthopedic · 21 CFR 888.3760 · Class 2_

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

## Overview

- **Product Code:** KWO
- **Device Name:** Prosthesis, Wrist, Carpal Scaphoid
- **Regulation:** [21 CFR 888.3760](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3760)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

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

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K864490](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWO/K864490.md) | SWANSON TITANIUM CARPAL SCAPHOID IMPLANT | Dow Corning Wright | Apr 15, 1987 | SESE |

## Top Applicants

- Dow Corning Wright — 1 clearance

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

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