510(k) Report

Devices descending from K132820

5 later devices reach Vilex Ultima External Fixation System with HA Coated Pins and Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+1K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+2K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+2K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+3K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—