Prosthesis, Wrist, Hemi-, Ulnar
FDA product code KXE · Class II (moderate risk) · 21 CFR 888.3810 · Orthopedic
16510(k) clearances
0PMA approvals
3recalls
Implantimplanted device
Manufacturers
- Aptis Medical, LLC 5
- Avanta Orthopaedics, Inc. 2
- Cutter Laboratories, Inc. 1
- Dow Corning Corp. Healthcare Industries Materials 1
- Wrightmedicaltechnologyinc 1
- Kapp Surgical Instrument, Inc. 1
- Stuckenbrock Medizintechnik GmbH 1
- Ascension Orthopedics, Inc. 1
- Small Bone Innovations, Inc. 1
- Remi Sciences, Inc. 1
- Ascension Orthopedic 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 05/03/2019SE |
| K142569 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 04/03/2015SE |
| K112481 | First Choice Druj System, Partial Head ImplantKXE · Traditional | Ascension Orthopedic | 04/09/2012SE |
| K081025 | IsoelasticuKXE · Traditional | Remi Sciences, Inc. | 11/21/2008SE |
| K082839 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 10/24/2008SE |
| K061146 | Sbi Ulnar Head ImplantKXE · Special | Small Bone Innovations, Inc. | 07/19/2006SE |
| K053119 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 12/07/2005SE |
| K052137 | Ascension MuhKXE · Traditional | Ascension Orthopedics, Inc. | 11/03/2005SE |
| K040497 | Distal Radio-Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 01/26/2005SE |
| K042902 | Herbert Ulnar Head Prosthesis SystemKXE · Traditional | Stuckenbrock Medizintechnik GmbH | 12/27/2004SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | Kapp Surgical Instrument, Inc. | 07/28/2004SE |
| K020274 | WMT Modular Ulnar Head ImplantKXE · Traditional | Wrightmedicaltechnologyinc | 02/22/2002SE |
| K010786 | Ulnar Head ImplantKXE · Special | Avanta Orthopaedics, Inc. | 04/11/2001SE |
| K982268 | Ulnar Head ImplantKXE · Traditional | Avanta Orthopaedics, Inc. | 12/04/1998SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | Dow Corning Corp. Healthcare Industries Materials | 08/18/1981SE |
| K790125 | Ulnar Head ProthesisKXE · Traditional | Cutter Laboratories, Inc. | 02/08/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2430-2015 Class II | Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for…Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity… | Stryker Howmedica Osteonics Corp. | 06/24/2015Terminated |
| Z-2427-2015 Class II | uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement…Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity… | Stryker Howmedica Osteonics Corp. | 06/24/2015Terminated |
| Z-1060-2012 | Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes…A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the… | Ascension Orthopedics, Inc | 12/03/2011Terminated |