Home / Device Classification / JWJ

JWJ — Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Class II

FDA Device Classification

Classification Details

Product Code
JWJ
Device Class
Class II
Regulation Number
888.3800
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243381skeletal dynamicsTotal Wrist Arthroplasty System (TWA)November 1, 2024
K233574skeletal dynamicsTotal Wrist Arthroplasty System (TWA)July 3, 2024
K233674ascension orthopedicsFreedom Wrist Arthroplasty SystemMay 30, 2024
K200718arthrosurfaceArthrosurface WristMotion Total Wrist Arthroplasty SystemOctober 15, 2020
K191525extremity medicalKinematX Total Wrist Arthroplasty SystemMarch 4, 2020
K132250integra lifesciences corporationINTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEMMarch 24, 2014
K080426biomet manufacturingMAESTRO WRIST FRACTURE IMPLANTJuly 29, 2008
K042032biometMAESTRO TOTAL WRISTOctober 7, 2004
K031203depuy orthopaedicsBIAX A.F. WRIST/BIAX ADVANCED FIXATION WRISTJuly 14, 2003
K030037kinetikos medicalUNIVERSAL TOTAL WRIST SYSTEMFebruary 5, 2003
K021859avanta orthopaedicsWRIST IMPLANTDecember 2, 2002
K020554kinetikos medicalMODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEMMay 3, 2002
K982156pasco laboratoriesPASCO MIC AND MIC/ID PANELS/ CEFDINIRJuly 29, 1998
K961051kinetikos medicalUNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)June 6, 1996
K931131smith and nephew richardsTHE RICHARDS WRISTAugust 19, 1994
K802032mick radio-nuclear instrumentsMINI MICK APPLICATOROctober 23, 1980
K792650zimmerHAMAS PRECENTERED TOTAL WRISTJanuary 28, 1980