510(k) Report

Devices descending from K011533

378 later devices reach Depuy Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+8K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+8K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+8K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+8K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+8K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+8K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+8K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+8K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K230078TRAX® CR Total Knee SystemAmplitude20230—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+8K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+8K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+8K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+8K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+8K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+8K211938Physica LMC Knee SystemLimacorporate20210—
+8K210551Persona Revision Knee SystemZimmer, Inc.202101
+8K201084Physica systemLima Corporate S.P.A.20205—
+8K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+8K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+8K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+8K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+8K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+8K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+8K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K171249Entrada™ hip stemOrtho Development Corporation20172—
+8K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+8K130634Corin Metafix Hip StemCorin USA20135—
+8K121563Corin Trifit TS HipCorin USA2012101
+8K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+9K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+9K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+9K251166Mfinity Femoral SystemMedacta International S.A.20250—
+9K251052Trivicta® Hip StemOrtho Development Corp.20250—
+9K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+9K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+9K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+9K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+9K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+9K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+9K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+9K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+9K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K211703Insignia Hip StemStryker Orthopaedics20217—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+9K210554Physica systemLima Corporate S.P.A.20212—
+9K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+9K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+9K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+9K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+9K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+10K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+10K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+10K221104Actera™ hip systemConformis, Inc.202211
+11K231178ACTERA™ hip systemConformis, Inc.20230—