510(k) Report

Devices descending from K994415

194 later devices reach Marathon Cross-Linked Polyethylene Acetabular Cup Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122641Mpact ExtensionMedacta International201214—
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+3K111145Endo HeadMedacta International20110—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+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—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+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—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+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—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+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—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec 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—
+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—
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+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—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+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—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211
+8K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+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—