510(k) Report

Devices descending from K030037

8 later devices reach Universal Total Wrist System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132250Integra Freedom Wrist Arthroplasty SystemIntegra LifeSciences Corporation20142—
+1K042032Maestro Total WristBiomet, Inc.20047—
+2K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.20240—
+2K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.20200—
+2K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC20200—
+2K080426Maestro Wrist Fracture ImplantBiomet Manufacturing Corp20080—
+2K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc.20053—
+3K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc.20141—