510(k) Report

Devices descending from K011489

40 later devices reach Summit Duofix Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+1K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+1K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+1K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+2K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+2K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+2K251166Mfinity Femoral SystemMedacta International S.A.20250—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K251052Trivicta® Hip StemOrtho Development Corp.20250—
+2K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+2K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+2K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+2K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+2K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+2K210678implaFit® hip stemsImplantcast GmbH20223—
+2K211703Insignia Hip StemStryker Orthopaedics20217—
+2K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+2K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+2K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+2K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K261576Icona Hip StemCorin, Ltd.20260—
+3K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K232371Actinia® hip stemsImplantcast GmbH20231—
+3K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+3K221104Actera™ hip systemConformis, Inc.202211
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—