510(k) Report

Devices descending from K160655

9 later devices reach OrthoButton CL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+1K171060OrthoButton ALRiverpoint Medical20178—
+2K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+2K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+2K240194ProCinch, QuadCinchRiverpoint Medical20240—
+2K233552IDEAL ZiploopRiverpoint Medical20230—
+2K230212OrthoButton ALRiverpoint Medical, LLC20232—
+2K202399OrthoButton FLRiverpoint Medical20201—
+3K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—