510(k) Report

Devices descending from K041356

247 later devices reach Arthrex Tenodesis Screw Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+1K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+1K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+1K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118—
+1K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY20071—
+1K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+2K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+2K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+2K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+2K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+2K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+2K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+2K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+2K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+2K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+2K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+2K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+2K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+2K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+2K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253115Lars AcjMovmedix S.A.S.20260—
+3K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+3K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+3K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+3K192810Apollo Suture Anchor SystemValeris Medical20201—
+3K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+3K192984APTUS Clavicle SystemMedartis AG20206—
+3K190143LARS AC Band DeviceCorin USA20191—
+3K191204Infinity Fixation SystemConmed Corporation20190—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K152255BoneCam Suture AnchorsValeris Medical20151—
+3K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+3K143092Tensyn PlugDallen Medical, Inc.20151—
+3K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K141420FastforwardMedShape, Inc.20145—
+3K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+3K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+3K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+3K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+3K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+3K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+3K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+4K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K230546SignexOsteonic Co., Ltd.20242—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+4K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—