Atlas FDA

JWJ

17 FDA 510(k) clearances · Product code

89 daysmedian time to decision
268 days90th percentile
17clearances measured

FDA profile

Official device name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3800
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2019: 127 · 2020: 34 · 2022: 65 · 2023: 26 · 2024: 18 · 2026: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Total Wrist Arthroplasty System (TWA) (K243381)Skeletal Dynamics, Inc.2024-11-01
Total Wrist Arthroplasty System (TWA) (K233574)Skeletal Dynamics2024-07-03
Freedom Wrist Arthroplasty System (K233674)Ascension Orthopedics, Inc.2024-05-30
Arthrosurface WristMotion Total Wrist Arthroplasty System (K200718)Arthrosurface, Inc.2020-10-15
KinematX Total Wrist Arthroplasty System (K191525)Extremity Medical, LLC2020-03-04
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (K132250)Integra LifeSciences Corporation2014-03-24
MAESTRO WRIST FRACTURE IMPLANT (K080426)Biomet Manufacturing Corp2008-07-29
MAESTRO TOTAL WRIST (K042032)Biomet, Inc.2004-10-07
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (K031203)DePuy Orthopaedics, Inc.2003-07-14
UNIVERSAL TOTAL WRIST SYSTEM (K030037)Kinetikos Medical, Inc.2003-02-05
WRIST IMPLANT (K021859)Avanta Orthopaedics, Inc.2002-12-02
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM (K020554)Kinetikos Medical, Inc.2002-05-03
PASCO MIC AND MIC/ID PANELS/ CEFDINIR (K982156)Pasco Laboratories, Inc.1998-07-29
UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) (K961051)Kinetikos Medical, Inc.1996-06-06
THE RICHARDS WRIST (K931131)Smith & Nephew Richards, Inc.1994-08-19
MINI MICK APPLICATOR (K802032)Mick Radio-Nuclear Instruments, Inc.1980-10-23
HAMAS PRECENTERED TOTAL WRIST (K792650)Zimmer, Inc.1980-01-28

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Every clearance here is in the API, with alerts when new ones post.