510(k) Report

Devices descending from K082239

14 later devices reach Depuy C-Stem Amt 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—
+1K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+1K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+1K152530UCP StemUnited Orthopedic Corporation20162—
+2K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+2K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—