510(k) Report

Devices descending from K951930

26 later devices reach Cementralizer Distal Stem Centralizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc.199825—
+2K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+2K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+2K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc.200114—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+3K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+3K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+3K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K152530UCP StemUnited Orthopedic Corporation20162—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—