510(k) Report

Devices descending from K160907

26 later devices reach DePuy Actis DuoFix Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261576Icona Hip StemCorin, Ltd.20260—
+1K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+1K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+1K251166Mfinity Femoral SystemMedacta International S.A.20250—
+1K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+1K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+1K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+1K211703Insignia Hip StemStryker Orthopaedics20217—
+1K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+1K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K221104Actera™ hip systemConformis, Inc.202211
+2K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+3K231178ACTERA™ hip systemConformis, Inc.20230—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—