510(k) Report

Devices descending from K061925

33 later devices reach Mini Tightrope Repair Kit, Model AR-8911DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+1K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+1K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+1K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+1K143092Tensyn PlugDallen Medical, Inc.20151—
+1K141420FastforwardMedShape, Inc.20145—
+1K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+1K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+1K090107Mini TightropeArthrex, Inc.200921—
+1K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+1K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+2K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+2K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+2K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+2K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+2K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+2K171703PUMA SystemPanther Orthopedics, Inc.20180—
+2K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+2K150359Tensyn PlugDallen Medical, Inc.20150—
+2K133275Mini TightropeArthrex, Inc.201411—
+2K111032CMC Cable FixInstratek, Inc.20112—
+3K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+3K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+3K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+3K140328CMC Mini TightropeArthrex, Inc.20146—
+4K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+4K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+4K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+4K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+4K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+6K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—