510(k) Report

Devices descending from K941847

312 later devices reach 5/8 Porocoat Aml Hip Porocoat Porous Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+10K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+10K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+10K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+10K130634Corin Metafix Hip StemCorin USA20135—
+10K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+11K250477NextAR (TM) SpineMedacta International S.A.20250—
+11K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+11K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+11K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+12K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+12K233172NextAR™ Spine PlatformMedacta International S.A.20241—