510(k) Report

Devices descending from K201522

7 later devices reach Arthrex Syndesmosis TightRope XP Buttress Plate Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+1K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+1K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+1K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+1K220650TriMed Ripcord DeviceTriMed, Inc.202211
+2K251134RipCordTriMed, Inc.20250—
+2K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—