510(k) Report

Devices descending from K211855

10 later devices reach Ion Facet Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251714Ion-CSurGenTec, LLC20260—
+1K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+1K243265Ion 3DSurGenTec, LLC20241—
+1K232468SC Medica FFXSc Medica20243—
+1K240086Ion 3DSurGenTec, LLC20243—
+1K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K252153FFX Facet Fixation SystemSc Medica20252—
+2K241416Ion 3DSurGenTec, LLC20242—
+3K261209Ion-LSurGenTec, LLC20260—
+3K250679FFX Facet Fixation SystemSc Medica20250—