Product code JWJ— Orthopedic
Total Wrist Arthroplasty System (TWA)
- Classification name
- Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- Device class
- Class 2
- Regulation
- 21 CFR 888.3800
- Advisory panel
- Orthopedic
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code JWJ
FDA has cleared devices under product code JWJ between 1980 and 2024, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2020
- 2014
- 2008
- 2004
- 2003
- 2002
- 1998
- 1996
- 1994
- 1980
Top applicants under product code JWJ
Adverse events under product code JWJ
product code JWJ- Injury
- 181
- Total
- 181
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JWJ
- K243381 — Total Wrist Arthroplasty System (TWA)
- K233574 — Total Wrist Arthroplasty System (TWA)
- K233674 — Freedom Wrist Arthroplasty System
- K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System
- K191525 — KinematX Total Wrist Arthroplasty System
- K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
- K080426 — MAESTRO WRIST FRACTURE IMPLANT
- K042032 — MAESTRO TOTAL WRIST
- K031203 — BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
- K030037 — UNIVERSAL TOTAL WRIST SYSTEM
- K021859 — WRIST IMPLANT
- K020554 — MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
- K982156 — PASCO MIC AND MIC/ID PANELS/ CEFDINIR
- K961051 — UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)
- K931131 — THE RICHARDS WRIST
- K802032 — MINI MICK APPLICATOR
- K792650 — HAMAS PRECENTERED TOTAL WRIST
Data sourced from openFDA. This site is unofficial and independent of the FDA.