KXE · Prosthesis, Wrist, Hemi-, Ulnar
Orthopedic · 21 CFR 888.3810 · Class 2
Overview
| Product Code | KXE |
|---|---|
| Device Name | Prosthesis, Wrist, Hemi-, Ulnar |
| Regulation | 21 CFR 888.3810 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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.
Cleared Devices (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | May 3, 2019 | SESE |
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | Apr 3, 2015 | SESE |
| K112481 | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | Ascension Orthopedic | Apr 9, 2012 | SESE |
| K081025 | ISOELASTICU | Remi Sciences, Inc. | Nov 21, 2008 | SESE |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | Oct 24, 2008 | SESE |
| K061146 | SBI ULNAR HEAD IMPLANT | Small Bone Innovations, Inc. | Jul 19, 2006 | SESE |
| K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | Dec 7, 2005 | SESE |
| K052137 | ASCENSION MUH | Ascension Orthopedics, Inc. | Nov 3, 2005 | SESE |
| K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | Jan 26, 2005 | SESE |
| K042902 | HERBERT ULNAR HEAD PROSTHESIS SYSTEM | Stuckenbrock Medizintechnik GmbH | Dec 27, 2004 | SESE |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Kapp Surgical Instrument, Inc. | Jul 28, 2004 | SESE |
| K020274 | WMT MODULAR ULNAR HEAD IMPLANT | Wrightmedicaltechnologyinc | Feb 22, 2002 | SESE |
| K010786 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | Apr 11, 2001 | SESE |
| K982268 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | Dec 4, 1998 | SESE |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Dow Corning Corp. Healthcare Industries Materials | Aug 18, 1981 | SESE |
| K790125 | ULNAR HEAD PROTHESIS | Cutter Laboratories, Inc. | Feb 8, 1979 | SESE |
Top Applicants
- Aptis Medical, LLC — 5 clearances
- Avanta Orthopaedics, Inc. — 2 clearances
- Wrightmedicaltechnologyinc — 1 clearance
- Stuckenbrock Medizintechnik GmbH — 1 clearance
- Small Bone Innovations, Inc. — 1 clearance
