510(k) Report

Devices descending from K940190

64 later devices reach Ultima Unipolar Modular Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063791Corin Unipolar Modular HeadCorin USA200763—
+2K111911Corin Optimom Modular HeadCorin USA201162—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K130634Corin Metafix Hip StemCorin USA20135—
+4K121563Corin Trifit TS HipCorin USA2012101
+4K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+5K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+5K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+5K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+5K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+9K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+9K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+9K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—