510(k) Report

Devices descending from K812672

14 later devices reach Self-Centering Hip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253357b-ONE® Bipolar HeadB-One Ortho, Corp.20260—
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+1K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+2K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—