510(k) Report

Devices descending from K133370

5 later devices reach Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+1K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+1K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+1K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+2K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—