510(k) Report

Devices descending from K151881

7 later devices reach X-Fix Line Additions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+1K212552Correx SoftwareVilex, LLC20210—
+1K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+1K173883External Fixation SystemLife Spine, Inc.20180—
+2K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+2K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+2K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—