510(k) Report

Devices descending from K060731

7 later devices reach Evolve Modular Radial Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260624Arthrex Radial Head Replacement SystemArthrex, Inc.20260—
+1K212872Avenger Radial Head SystemIn2bones USA, LLC20210—
+1K192754Avenger Radial Head SystemIn2bones USA, LLC20201—
+1K183618Revolution Radial HeadIgnite Orthopedics, Inc.201921
+1K132735Axia Radial Head SystemImds (Innovative MEdical Device Systems) - Leis ME20140—
+2K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+2K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes20220—