510(k) Report

Devices descending from K110123

8 later devices reach PCL Tightrope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+1K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+2K231857Arthrex TightRope IIArthrex, Inc.20234—
+2K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+3K241235Arthrex TightRope IIArthrex, Inc.20243—
+4K260405FiberTape ButtonArthrex, Inc.20260—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—