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
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+6K162035GMK SphereMedacta International S.A.201710—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+6K140826GMK Sphere ExtensionMedacta International201417—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K133630GMK Short StemMedacta International20131—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K123721GMK Revision ExtensionMedacta International20133—
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K122232GMK NarrowMedacta International20128—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+6K103721Mpact Acetabular SystemMedacta International201121—
+6K103352Versafitcup CC TrioMedacta International20114—
+6K102437GMK Revision Knee SystemMedacta International S.A.201034—
+6K093806Myknee Cutting BlocksMedacta International S.A.201016—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K241461Mpact Constrained LinerMedacta International S.A.20251—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230011Mpact ExtensionMedacta International S.A.20233—
+7K231037MyKnee UNI-STMedacta International S.A.20230—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K200391MPACT ExtensionMedacta International S.A.20210—
+7K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193559NextAR TKA PlatformMedacta Inernational SA202012—
+7K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+7K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+7K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K143453Mpact Double Mobility SystemMedacta International20151—
+7K132879Mpact ExtensionMedacta International201411—
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+7K131458Mpact DM Liner ConverterMedacta International20133—
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K122911Versafitcup CC Trio ExtensionMedacta International20121—
+7K122641Mpact ExtensionMedacta International201214—
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+7K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+7K111145Endo HeadMedacta International20110—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K211891DM Converter - TiN coatedMedacta International S.A.20220—
+8K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+8K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+8K211703Insignia Hip StemStryker Orthopaedics20217—