510(k) Report

Devices descending from K060031

18 later devices reach Depuy Modular M Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K120599Depuy M-Spec 36MM Femoral HeadsDepuy Orthopaedics20136—
+1K082585Depuy Asphere M-Spec HeadDePuy Orthopaedics, Inc.20087—
+1K071117Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc.200761
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC20240—
+2K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—