510(k) Report

Devices descending from K040191

267 later devices reach Bicontact Hip Stem and Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+6K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+6K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+6K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K202152NextAR TKA PlatformMedacta International S.A.202011—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K130634Corin Metafix Hip StemCorin USA20135—
+6K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K250477NextAR (TM) SpineMedacta International S.A.20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+7K211703Insignia Hip StemStryker Orthopaedics20217—
+7K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+8K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+8K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+8K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+8K221104Actera™ hip systemConformis, Inc.202211
+9K252067Velora Acetabular SystemRestor3D, Inc.20250—
+9K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+9K231178ACTERA™ hip systemConformis, Inc.20230—
+10K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+10K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+10K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—