510(k) Report

Devices descending from K221128

6 later devices reach Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231857Arthrex TightRope IIArthrex, Inc.20234—
+1K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+2K241235Arthrex TightRope IIArthrex, Inc.20243—
+3K260405FiberTape ButtonArthrex, Inc.20260—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—