510(k) Report

Devices descending from K080071

8 later devices reach Sidekick Rail Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+1K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—