510(k) Report

Devices descending from K982918

25 later devices reach Depuy C-Stem System through their predicates, nearest generation first.

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