510(k) Report

Devices descending from K012125

105 later devices reach Opus Magnum Anchor & Inserter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260405FiberTape ButtonArthrex, Inc.20260—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+8K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—