510(k) Report

Devices descending from K190344

11 later devices reach DePuy Corail AMT Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+1K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+1K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—