510(k) Report

Devices descending from K934765

391 later devices reach Trilogy Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+6K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+6K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+6K243839Alteon® HA Femoral StemsExactech, Inc.20250—
+6K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K201084Physica systemLima Corporate S.P.A.20205—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+6K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+6K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+7K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+7K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+7K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+7K211703Insignia Hip StemStryker Orthopaedics20217—
+7K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+7K210554Physica systemLima Corporate S.P.A.20212—
+7K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+7K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+8K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+8K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+8K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+8K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+8K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+9K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+10K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+10K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+10K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—