Product code JWJ

Device name: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Medical specialty: Orthopedic
Device class: 2
Regulation number: 888.3800
Review panel: OR
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K243381	Total Wrist Arthroplasty System (TWA)	Skeletal Dynamics, Inc.	2024-11-01
K233574	Total Wrist Arthroplasty System (TWA)	Skeletal Dynamics	2024-07-03
K233674	Freedom Wrist Arthroplasty System	Ascension Orthopedics, Inc.	2024-05-30
K200718	Arthrosurface WristMotion Total Wrist Arthroplasty System	Arthrosurface, Inc.	2020-10-15
K191525	KinematX Total Wrist Arthroplasty System	Extremity Medical, LLC	2020-03-04
K132250	INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM	Integra LifeSciences Corporation	2014-03-24
K080426	MAESTRO WRIST FRACTURE IMPLANT	Biomet Manufacturing Corp	2008-07-29
K042032	MAESTRO TOTAL WRIST	Biomet, Inc.	2004-10-07
K031203	BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST	DePuy Orthopaedics, Inc.	2003-07-14
K030037	UNIVERSAL TOTAL WRIST SYSTEM	Kinetikos Medical, Inc.	2003-02-05
K021859	WRIST IMPLANT	Avanta Orthopaedics, Inc.	2002-12-02
K020554	MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM	Kinetikos Medical, Inc.	2002-05-03
K982156	PASCO MIC AND MIC/ID PANELS/ CEFDINIR	Pasco Laboratories, Inc.	1998-07-29
K961051	UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)	Kinetikos Medical, Inc.	1996-06-06
K931131	THE RICHARDS WRIST	Smith & Nephew Richards, Inc.	1994-08-19
K802032	MINI MICK APPLICATOR	Mick Radio-Nuclear Instruments, Inc.	1980-10-23
K792650	HAMAS PRECENTERED TOTAL WRIST	Zimmer, Inc.	1980-01-28

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10381780065982	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066125	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066118	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066101	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066095	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066088	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066071	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066064	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066057	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066040	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066033	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066026	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066019	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780066002	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065999	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065975	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065968	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065951	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065944	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065937	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065920	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065913	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065906	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780065890	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780064916	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780064909	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780064893	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780064886	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780064879	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2017-10-09
10381780064336	Universal 2™ Total Wrist System	Ascension Orthopedics, Inc.	2015-08-15

Product code JWJ

Related 510(k) Records#

Related GUDID Devices#