510(k) Report

Devices descending from K961051

14 later devices reach Universal Total Wrist System (Modification) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030037Universal Total Wrist SystemKinetikos Medical, Inc.20038—
+1K021859Wrist ImplantAvanta Orthopaedics, Inc.20024—
+1K020554Modification to Universal Total Wrist SystemKinetikos Medical, Inc.200210—
+2K233574Total Wrist Arthroplasty System (TWA)Skeletal Dynamics20241—
+2K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.20200—
+2K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC20200—
+2K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation20142—
+2K042032Maestro Total WristBiomet, Inc.20047—
+2K031203Biax a.F. Wrist/Biax Advanced Fixation WristDePuy Orthopaedics, Inc.20038—
+3K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc.20240—
+3K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.20240—
+3K080426Maestro Wrist Fracture ImplantBiomet Manufacturing Corp20080—
+3K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc.20053—
+4K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc.20141—