FDA 510(k) Applications for Medical Device Product Code "JWJ"
(Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200718 | Arthrosurface, Inc. | Arthrosurface WristMotion Total Wrist Arthroplasty System | 10/15/2020 |
| K233674 | Ascension Orthopedics, Inc. | Freedom Wrist Arthroplasty System | 05/30/2024 |
| K021859 | AVANTA ORTHOPAEDICS, INC. | WRIST IMPLANT | 12/02/2002 |
| K080426 | BIOMET MANUFACTURING CORP. | MAESTRO WRIST FRACTURE IMPLANT | 07/29/2008 |
| K042032 | BIOMET, INC. | MAESTRO TOTAL WRIST | 10/07/2004 |
| K031203 | DEPUY ORTHOPAEDICS, INC. | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST | 07/14/2003 |
| K191525 | Extremity Medical, LLC. | KinematX Total Wrist Arthroplasty System | 03/04/2020 |
| K132250 | INTEGRA LIFE SCIENCES CORPORATION | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | 03/24/2014 |
| K020554 | KINETIKOS MEDICAL, INC. | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | 05/03/2002 |
| K030037 | KINETIKOS MEDICAL, INC. | UNIVERSAL TOTAL WRIST SYSTEM | 02/05/2003 |
| K961051 | KINETIKOS MEDICAL, INC. | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) | 06/06/1996 |
| K982156 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS/ CEFDINIR | 07/29/1998 |
| K233574 | Skeletal Dynamics | Total Wrist Arthroplasty System (TWA) | 07/03/2024 |
| K243381 | Skeletal Dynamics Inc | Total Wrist Arthroplasty System (TWA) | 11/01/2024 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
