510(k) Report

Devices descending from K031803

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+7K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+7K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+7K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+7K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+7K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230078TRAX® CR Total Knee SystemAmplitude20230—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+7K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K211938Physica LMC Knee SystemLimacorporate20210—
+7K210551Persona Revision Knee SystemZimmer, Inc.202101
+7K201084Physica systemLima Corporate S.P.A.20205—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+7K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+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—
+7K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K121563Corin Trifit TS HipCorin USA2012101
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+8K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+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—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+8K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K211703Insignia Hip StemStryker Orthopaedics20217—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K210554Physica systemLima Corporate S.P.A.20212—
+8K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+9K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+9K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+9K221104Actera™ hip systemConformis, Inc.202211
+10K231178ACTERA™ hip systemConformis, Inc.20230—