510(k) Report

Devices descending from K193398

20 later devices reach Summit DuoFix HA Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210678implaFit® hip stemsImplantcast GmbH20223—
+1K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+2K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K252401implaFit® short stemsImplantcast GmbH20260—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K232371Actinia® hip stemsImplantcast GmbH20231—
+2K211703Insignia Hip StemStryker Orthopaedics20217—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—