510(k) Report

Devices descending from K163487

4 later devices reach Ultima HA Coated Half Pins and Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+1K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+2K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—