510(k) Report

Devices descending from K090107

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+1K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+1K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+1K171703PUMA SystemPanther Orthopedics, Inc.20180—
+1K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+1K133275Mini TightropeArthrex, Inc.201411—
+1K111032CMC Cable FixInstratek, Inc.20112—
+2K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+2K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+2K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+2K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+2K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+2K140328CMC Mini TightropeArthrex, Inc.20146—
+3K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+3K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+3K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+3K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+3K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+3K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+3K143092Tensyn PlugDallen Medical, Inc.20151—
+4K150359Tensyn PlugDallen Medical, Inc.20150—