510(k) Report

Devices descending from K010171

239 later devices reach Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+3K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+3K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+3K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+3K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+4K132879Mpact ExtensionMedacta International201411—
+4K131518Mectacer Biolox Option HeadsMedacta International20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K130634Corin Metafix Hip StemCorin USA20135—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K121563Corin Trifit TS HipCorin USA2012101
+4K122641Mpact ExtensionMedacta International201214—
+4K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111145Endo HeadMedacta International20110—
+4K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+5K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+5K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+5K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+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—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—