510(k) Report

Devices descending from K002960

247 later devices reach Trilogy Acetabular System Large Head Liner, Model 6353 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+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—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+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—
+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—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+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—
+8K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+8K221104Actera™ hip systemConformis, Inc.202211
+9K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+9K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+9K231178ACTERA™ hip systemConformis, Inc.20230—
+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—