510(k) Report

Devices descending from K974186

6 later devices reach Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+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—