510(k) Report

Devices descending from K231857

4 later devices reach Arthrex TightRope II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241235Arthrex TightRope IIArthrex, Inc.20243—
+2K260405FiberTape ButtonArthrex, Inc.20260—
+2K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+2K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—