510(k) Report

Devices descending from K972596

198 later devices reach Depuy Duraloc Acetabular Cup System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K132879Mpact ExtensionMedacta International201411—
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131986Corin Minihip StemCorin USA20133—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+4K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+4K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+4K111145Endo HeadMedacta International20110—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K130634Corin Metafix Hip StemCorin USA20135—
+5K121563Corin Trifit TS HipCorin USA2012101
+5K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+7K211703Insignia Hip StemStryker Orthopaedics20217—
+7K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+7K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+8K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+8K221104Actera™ hip systemConformis, Inc.202211
+9K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+9K231178ACTERA™ hip systemConformis, Inc.20230—
+10K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+10K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+10K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—