510(k) Report

Devices descending from K231504

3 later devices reach TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+1K250304TITANEX Screw SystemsVilex, LLC20251—
+2K260900DYNEX® External Fixation SystemsVilex, LLC20260—