510(k) Report

Devices descending from K082525

71 later devices reach Corin Metafix Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241472Icona Hip StemCorin U.S.A. Limited20241—
+1K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+1K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+1K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+1K131952Corin Metafix Hip StemCorin USA20134—
+1K130634Corin Metafix Hip StemCorin USA20135—
+1K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+1K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+1K103518Trinity Acetabular SystemCorin USA20118—
+2K261576Icona Hip StemCorin, Ltd.20260—
+2K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K121563Corin Trifit TS HipCorin USA2012101
+3K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+3K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+3K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+3K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+3K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+3K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+3K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+3K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K251166Mfinity Femoral SystemMedacta International S.A.20250—
+4K251052Trivicta® Hip StemOrtho Development Corp.20250—
+4K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+4K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+4K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+4K211703Insignia Hip StemStryker Orthopaedics20217—
+4K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+4K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+4K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+4K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+4K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+5K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+5K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+5K221104Actera™ hip systemConformis, Inc.202211
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+7K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+7K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+7K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—