510(k) Report

Devices descending from K010243

74 later devices reach Tri-Fit Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+1K111911Corin Optimom Modular HeadCorin USA201162—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+2K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+2K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+3K131952Corin Metafix Hip StemCorin USA20134—
+3K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+3K130634Corin Metafix Hip StemCorin USA20135—
+3K121563Corin Trifit TS HipCorin USA2012101
+3K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+4K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+4K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+4K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+4K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+4K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+4K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+4K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K251166Mfinity Femoral SystemMedacta International S.A.20250—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+5K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+5K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+5K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+5K211703Insignia Hip StemStryker Orthopaedics20217—
+5K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+5K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+5K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+5K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+6K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+6K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+6K221104Actera™ hip systemConformis, Inc.202211
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K252067Velora Acetabular SystemRestor3D, Inc.20250—
+7K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+8K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+8K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+8K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—