510(k) Report

Devices descending from K052196

13 later devices reach Vilex X-Fix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202143Dynex MicroVilex, LLC20201—
+1K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+1K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+1K140158S.E.a.L. Fracture Fusion TubeDne, LLC20140—
+1K100857Fusion Medical Ring Lock SystemJohn J Riccio20101—
+2K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+2K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+2K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+2K212552Correx SoftwareVilex, LLC20210—
+2K200343FusionFrame Ring Lock SystemGlw Medical Innovation20200—
+2K173883External Fixation SystemLife Spine, Inc.20180—
+3K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—