510(k) Report

Devices descending from K961186

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+1K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…Depuy, Inc.2004118—
+1K983491Depuy Duraloc Acetabular Cup System-Enduron LinerDePuy Orthopaedics, Inc.19981—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K093472Trinity Acetabular SystemCorin USA20101171
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+3K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K142761Corin TaperFit Hip StemCorin USA201541
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K130128Trinity Acetabular SystemCorin Medical201317—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+3K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+3K121563Corin Trifit TS HipCorin USA2012101
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+3K103518Trinity Acetabular SystemCorin USA20118—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+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—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131986Corin Minihip StemCorin USA20133—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+4K111911Corin Optimom Modular HeadCorin USA201162—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K130634Corin Metafix Hip StemCorin USA20135—
+6K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+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—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+8K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+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—