510(k) Report

Devices descending from K133275

11 later devices reach Mini Tightrope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+1K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+1K140328CMC Mini TightropeArthrex, Inc.20146—
+2K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+2K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+2K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+2K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+2K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+2K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+2K143092Tensyn PlugDallen Medical, Inc.20151—
+3K150359Tensyn PlugDallen Medical, Inc.20150—