510(k) Report

Devices descending from K955033

328 later devices reach Rim Flare Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+10K211703Insignia Hip StemStryker Orthopaedics20217—
+10K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+10K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+10K210153NextAR RSA PlatformMedacta International S.A.202151
+10K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+10K202152NextAR TKA PlatformMedacta International S.A.202011—
+10K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+10K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+10K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+10K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+10K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+10K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+11K250477NextAR (TM) SpineMedacta International S.A.20250—
+11K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+11K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+11K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+11K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+11K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+11K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+11K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+11K221104Actera™ hip systemConformis, Inc.202211
+12K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+12K252067Velora Acetabular SystemRestor3D, Inc.20250—
+12K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+12K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+12K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+12K231178ACTERA™ hip systemConformis, Inc.20230—