JWJ — Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Class II
FDA product code JWJ covers "Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained", a Class II medical device regulated under 21 CFR 888.3800. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JWJ
- Device Class
- Class II
- Regulation Number
- 888.3800
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243381 | skeletal dynamics | Total Wrist Arthroplasty System (TWA) | November 1, 2024 |
| K233574 | skeletal dynamics | Total Wrist Arthroplasty System (TWA) | July 3, 2024 |
| K233674 | ascension orthopedics | Freedom Wrist Arthroplasty System | May 30, 2024 |
| K200718 | arthrosurface | Arthrosurface WristMotion Total Wrist Arthroplasty System | October 15, 2020 |
| K191525 | extremity medical | KinematX Total Wrist Arthroplasty System | March 4, 2020 |
| K132250 | integra lifesciences corporation | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | March 24, 2014 |
| K080426 | biomet manufacturing | MAESTRO WRIST FRACTURE IMPLANT | July 29, 2008 |
| K042032 | biomet | MAESTRO TOTAL WRIST | October 7, 2004 |
| K031203 | depuy orthopaedics | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST | July 14, 2003 |
| K030037 | kinetikos medical | UNIVERSAL TOTAL WRIST SYSTEM | February 5, 2003 |
| K021859 | avanta orthopaedics | WRIST IMPLANT | December 2, 2002 |
| K020554 | kinetikos medical | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | May 3, 2002 |
| K982156 | pasco laboratories | PASCO MIC AND MIC/ID PANELS/ CEFDINIR | July 29, 1998 |
| K961051 | kinetikos medical | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) | June 6, 1996 |
| K931131 | smith and nephew richards | THE RICHARDS WRIST | August 19, 1994 |
| K802032 | mick radio-nuclear instruments | MINI MICK APPLICATOR | October 23, 1980 |
| K792650 | zimmer | HAMAS PRECENTERED TOTAL WRIST | January 28, 1980 |