510(k) Report

Devices descending from K983035

219 later devices reach Custom Flanged Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+9K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+9K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K211891DM Converter - TiN coatedMedacta International S.A.20220—
+9K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+9K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+9K210153NextAR RSA PlatformMedacta International S.A.202151
+9K202152NextAR TKA PlatformMedacta International S.A.202011—
+10K250477NextAR (TM) SpineMedacta International S.A.20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+11K233172NextAR™ Spine PlatformMedacta International S.A.20241—