Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JWJ — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
268 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | 2024-11-01 | 2 | 0 |
| K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | 2024-07-03 | 239 | 0 |
| K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 2024-05-30 | 196 | 0 |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | 2020-10-15 | 210 | 0 |
| K191525 | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | 2020-03-04 | 268 | 0 |
| K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | Integra LifeSciences Corporation | 2014-03-24 | 248 | 0 |
| K080426 | MAESTRO WRIST FRACTURE IMPLANT | Biomet Manufacturing Corp | 2008-07-29 | 160 | 0 |
| K042032 | MAESTRO TOTAL WRIST | Biomet, Inc. | 2004-10-07 | 71 | 0 |
| K031203 | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST | DePuy Orthopaedics, Inc. | 2003-07-14 | 89 | 0 |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | 2003-02-05 | 30 | 0 |
| K021859 | WRIST IMPLANT | Avanta Orthopaedics, Inc. | 2002-12-02 | 179 | 0 |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | 2002-05-03 | 72 | 0 |
| K982156 | PASCO MIC AND MIC/ID PANELS/ CEFDINIR | Pasco Laboratories, Inc. | 1998-07-29 | 41 | 0 |
| K961051 | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) | Kinetikos Medical, Inc. | 1996-06-06 | 87 | 0 |
| K931131 | THE RICHARDS WRIST | Smith & Nephew Richards, Inc. | 1994-08-19 | 532 | 0 |
| K802032 | MINI MICK APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1980-10-23 | 62 | 0 |
| K792650 | HAMAS PRECENTERED TOTAL WRIST | Zimmer, Inc. | 1980-01-28 | 38 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda