510(k) Report

Devices descending from K000392

29 later devices reach Response 2000 Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030122Depuy Summit Basic Press-Fit Hip StemDePuy Orthopaedics, Inc.200328—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+3K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+3K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K251166Mfinity Femoral SystemMedacta International S.A.20250—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K211703Insignia Hip StemStryker Orthopaedics20217—
+6K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+8K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+8K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+8K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+8K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—