510(k) Report

Devices descending from K041189

40 later devices reach Arthrex Trimit Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+1K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+1K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+1K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+2K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+2K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+2K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+2K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+2K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+2K143092Tensyn PlugDallen Medical, Inc.20151—
+2K141420FastforwardMedShape, Inc.20145—
+2K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+2K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+2K090107Mini TightropeArthrex, Inc.200921—
+2K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+2K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+3K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+3K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+3K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+3K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+3K150359Tensyn PlugDallen Medical, Inc.20150—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K111032CMC Cable FixInstratek, Inc.20112—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+4K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140328CMC Mini TightropeArthrex, Inc.20146—
+5K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+5K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+5K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+5K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+5K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+6K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+7K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—