510(k) Report

Devices descending from K033273

210 later devices reach Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K131986Corin Minihip StemCorin USA20133—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+3K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K102423Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.2010172
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242833Legend® Acetabular ShellOrtho Development Corp.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+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—
+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—
+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—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132959Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.201413—
+4K132879Mpact ExtensionMedacta International201411—
+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
+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—
+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—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+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—
+5K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+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—
+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—
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+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—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+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—