510(k) Report

Devices descending from K113242

52 later devices reach Apex Arc Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+1K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+2K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+2K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+2K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+2K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+2K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+2K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+2K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+2K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+2K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+2K171249Entrada™ hip stemOrtho Development Corporation20172—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+2K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+3K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K251166Mfinity Femoral SystemMedacta International S.A.20250—
+3K251052Trivicta® Hip StemOrtho Development Corp.20250—
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+3K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+3K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+3K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+3K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+3K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+3K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K221104Actera™ hip systemConformis, Inc.202211
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+6K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+6K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+6K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—