510(k) Report

Devices descending from K091967

9 later devices reach Medacta Bipolar Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241461Mpact Constrained LinerMedacta International S.A.20251—
+1K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+1K132539Ring-Lok Modular Bipolar SystemImplants International, Ltd.20140—
+2K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+2K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+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—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—