Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3810](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3810) → KXE — Prosthesis, Wrist, Hemi-, Ulnar

# KXE · Prosthesis, Wrist, Hemi-, Ulnar

_Orthopedic · 21 CFR 888.3810 · Class 2_

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

## Overview

- **Product Code:** KXE
- **Device Name:** Prosthesis, Wrist, Hemi-, Ulnar
- **Regulation:** [21 CFR 888.3810](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3810)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

## Classification Rationale

Class II.

## Recent Cleared Devices (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K190599](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K190599.md) | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | May 3, 2019 | SESE |
| [K142569](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K142569.md) | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | Apr 3, 2015 | SESE |
| [K112481](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K112481.md) | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | Ascension Orthopedic | Apr 9, 2012 | SESE |
| [K081025](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K081025.md) | ISOELASTICU | Remi Sciences, Inc. | Nov 21, 2008 | SESE |
| [K082839](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K082839.md) | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | Oct 24, 2008 | SESE |
| [K061146](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K061146.md) | SBI ULNAR HEAD IMPLANT | Small Bone Innovations, Inc. | Jul 19, 2006 | SESE |
| [K053119](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K053119.md) | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | Dec 7, 2005 | SESE |
| [K052137](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K052137.md) | ASCENSION MUH | Ascension Orthopedics, Inc. | Nov 3, 2005 | SESE |
| [K040497](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K040497.md) | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | Jan 26, 2005 | SESE |
| [K042902](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K042902.md) | HERBERT ULNAR HEAD PROSTHESIS SYSTEM | Stuckenbrock Medizintechnik GmbH | Dec 27, 2004 | SESE |
| [K033930](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K033930.md) | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Kapp Surgical Instrument, Inc. | Jul 28, 2004 | SESE |
| [K020274](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K020274.md) | WMT MODULAR ULNAR HEAD IMPLANT | Wrightmedicaltechnologyinc | Feb 22, 2002 | SESE |
| [K010786](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K010786.md) | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | Apr 11, 2001 | SESE |
| [K982268](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K982268.md) | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | Dec 4, 1998 | SESE |
| [K812053](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K812053.md) | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Dow Corning Corp. Healthcare Industries Materials | Aug 18, 1981 | SESE |
| [K790125](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXE/K790125.md) | ULNAR HEAD PROTHESIS | Cutter Laboratories, Inc. | Feb 8, 1979 | SESE |

## Top Applicants

- Aptis Medical, LLC — 5 clearances
- Avanta Orthopaedics, Inc. — 2 clearances
- Ascension Orthopedic — 1 clearance
- Ascension Orthopedics, Inc. — 1 clearance
- Cutter Laboratories, Inc. — 1 clearance

---

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

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