510(k) Report

Devices descending from K003379

178 later devices reach V-40/C-Taper Adapter Sleeve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K131986Corin Minihip StemCorin USA20133—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+6K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K130634Corin Metafix Hip StemCorin USA20135—
+6K121563Corin Trifit TS HipCorin USA2012101
+6K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K211703Insignia Hip StemStryker Orthopaedics20217—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K221104Actera™ hip systemConformis, Inc.202211
+10K252067Velora Acetabular SystemRestor3D, Inc.20250—
+10K231178ACTERA™ hip systemConformis, Inc.20230—