Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Orthopedic · 21 CFR 888.3800
Recent MDR events
497 adverse event reports on file
- KINEMATX TOTALJul 15, 2026MalfunctionExtremity Medical, Llc.3007289093-2026-00002
- WRISTMOTIONTOTAL WRIST ARTHROPLATY SYSTEMJul 2, 2026MalfunctionArthrosurface, Inc.3004154314-2026-00003
- KINEMATX TOTALMay 12, 2026InjuryExtremity Medical, Llc.3007289093-2026-00001
- UNK_REMOTION IMPLANTJan 21, 2026InjuryStryker Gmbh0008031020-2026-00076
- UNK_REMOTION IMPLANTJan 21, 2026InjuryStryker Gmbh0008031020-2026-00077
- UNK_REMOTION IMPLANTJan 20, 2026InjuryStryker Gmbh0008031020-2026-00051
- UNK_REMOTION IMPLANTJan 20, 2026InjuryStryker Gmbh0008031020-2026-00052
- UNK_REMOTION IMPLANTJan 20, 2026InjuryStryker Gmbh0008031020-2026-00055
- UNK_REMOTION IMPLANTJan 20, 2026InjuryStryker Gmbh0008031020-2026-00050
- UNK_REMOTION IMPLANTJan 20, 2026InjuryStryker Gmbh0008031020-2026-00054
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
53 firms currently registered for this product code
Extremity Medical, Llc
Parsippany, NJ, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Sterigenics Us Llc
West Memphis, AR, US
Biomet, Inc.
WARSAW, IN, US
Smt Schilling Metalltechnik Gmbh
MUHLHEIM Baden-Wurttemberg, DE
Smith & Nephew, Inc.
MEMPHIS, TN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Sterigenics Us, Llc
Lewis Center, OH, US
Rms Co.
MINNEAPOLIS, MN, US
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Arthrosurface, Inc.
W Bridgewater, MA, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Zimmer Pte. Ltd.
Singapore South East, SG
Orchid Orthopedics-chelsea
Chelsea, MI, US
Isomedix Operations, Inc.
Libertyville, IL, US
Instrumed International Inc Dba Avalign German Specialty Instruments
SCHAUMBURG, IL, US
Onyx Medical Llc
MEMPHIS, TN, US
Orchid Orthopedics Switzerland Gmbh
Baden-Daettwil Aargau, CH
Metal Craft Machine & Engineering, Inc.
Elk River, MN, US
Arch Medical Solutions - Warsaw
Warsaw, IN, US
510(k) clearances
17 clearances for this product code
- Skeletal Dynamics, Inc.Nov 1, 2024
K243381 · Total Wrist Arthroplasty System (TWA)
- Skeletal DynamicsJul 3, 2024
K233574 · Total Wrist Arthroplasty System (TWA)
- Ascension Orthopedics, Inc.May 30, 2024
K233674 · Freedom Wrist Arthroplasty System
- Arthrosurface, Inc.Oct 15, 2020
K200718 · Arthrosurface WristMotion Total Wrist Arthroplasty System
- Extremity Medical, LLCMar 4, 2020
K191525 · KinematX Total Wrist Arthroplasty System
- Integra LifeSciences CorporationMar 24, 2014
K132250 · INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
- Biomet Manufacturing CorpJul 29, 2008
K080426 · MAESTRO WRIST FRACTURE IMPLANT
- Biomet, Inc.Oct 7, 2004
K042032 · MAESTRO TOTAL WRIST