510(k) Report

Devices descending from K002575

326 later devices reach Inter-OP Durasul Acetabular Inserts (4MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+4K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+4K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+4K093472Trinity Acetabular SystemCorin USA20101171
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K083312Minihip StemCorin USA201015—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081023Evolis Total Knee SystemMedacta International S.A.2008781
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+5K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+5K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142069GMK ExtensionMedacta International20144—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K131986Corin Minihip StemCorin USA20133—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K131310GMK Full PE Tibial ComponentsMedacta International20132—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K121563Corin Trifit TS HipCorin USA2012101
+5K121416GMK SphereMedacta International201220—
+5K120790GMK - Line ExtensionMedacta International201211—
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K113571GMK Resufacing Patella Size 4Medacta International201223—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111911Corin Optimom Modular HeadCorin USA201162—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K111283GMK Revision Hybrid LinersMedacta International20110—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K090988GMK Total Knee SystemMedacta International S.A.2009521
+5K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+6K262057GMK ExtensionMedacta International SA20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—