510(k) Report

Devices descending from K043174

16 later devices reach Stealth Fusion System, Model RR 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162033SALVATION External Fixation SystemWright Medical20173—
+1K052196Vilex X-FixVilex, Inc.200513—
+2K202143Dynex MicroVilex, LLC20201—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K173883External Fixation SystemLife Spine, Inc.20180—
+2K180832SALVATION External Fixation SystemWrightmedicaltechnologyinc20181—
+2K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+2K140158S.E.a.L. Fracture Fusion TubeDne, LLC20140—
+2K100857Fusion Medical Ring Lock SystemJohn J Riccio20101—
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+3K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+3K212552Correx SoftwareVilex, LLC20210—
+3K200343FusionFrame Ring Lock SystemGlw Medical Innovation20200—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—