510(k) Report

Devices descending from K010673

292 later devices reach Arthrex Fiberwire, Model Spu-02NB-3800 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041553Arthrex Suture Grafting KitArthrex, Inc.200431—
+1K041894OrthofiberCp Medical20044—
+1K040004Orthocord SutureDepuy Mitek2004431
+1K033718Maxbraid Polyester Plus and Polyethylene Plus SutureArthrotek, Inc.20040—
+1K032245Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…Arthrex, Inc.200437—
+1K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+1K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002259—
+1K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001260—
+2K213046AceConnex Pre-Sutured FasciaAllosource20230—
+2K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+2K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation201921
+2K181182DYNACORD SutureMedos International SARL20181—
+2K170957ReConnex Pre-Sutured TendonAllosource20183—
+2K162247PermatapeMedos International SARL20161—
+2K161638SPEEDTRAP Graft Preparation SystemMedos International SARL20160—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+2K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+2K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+2K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+2K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+2K112899Arthrex Bio-SutureArthrex, Inc.20123—
+2K100652Acl TightropeArthrex, Inc.201065—
+2K094028CP-Fiber (Orthofiber)Cp Medical20100—
+2K091202Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying…Medshape Solutions20093—
+2K090107Mini TightropeArthrex, Inc.200921—
+2K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions20094—
+2K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+2K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+2K080918Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…Depuy Mitek20080—
+2K071796Capsew Plication SystemCayenne Medical, Inc.20070—
+2K071622Arthrex FiberwireArthrex, Inc.20073—
+2K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical2007691
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+2K052901Arthrex TensionlokArthrex, Inc.20050—
+2K050150Mani Needle & Suture PackMani, Inc.20050—
+2K043298Blue Orthocord SutureDepuy Mitek2004336
+2K042233Passing Needle with Ethibond, Panacryl or Orthocord SutureDepuy Mitek, A Johnson & Johnson Company20040—
+2K041589Arthrex Fiberwire with SilkArthrex, Inc.20044—
+2K041806Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with…Depuy Mitek, A Johnson & Johnson Company20041—
+3K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+3K260018Arthrex FiberButtonArthrex, Inc.20260—
+3K260405FiberTape ButtonArthrex, Inc.20260—
+3K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+3K252225PowerKnot High Strength SuturesMedacta International S.A.20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+3K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+3K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+3K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…Rti Surgical, Inc.20231—
+3K223822Activbraid™Embody, Inc.20230—
+3K220880Arthrex BioSutureArthrex, Inc.20220—
+3K220219PERMALOOP Suture, PERMATAPE SutureMedos International SARL20220—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K211049Tigon Medical Button SystemTigon Medical20210—
+3K203186DYNATAPE SutureMedos International SARL20210—
+3K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+3K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+3K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+3K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+3K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K172016Force Fiber Fusion SutureTeleflex Medical Incorporated20171—
+3K170642GRAVITY™ Soft Tissue Repair SystemWrightmedicaltechnologyinc20170—
+3K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+3K171296SutureTapeArthrex, Inc.20173—
+3K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+3K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K143356NovoStitch Plus Meniscal Repair SystemCeterix Orthopaedics, Inc.20152—
+3K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2Dunamis, LLC20150—
+3K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.201514—
+3K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+3K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K140019Arthrex BiosutureArthrex, Inc.20141—
+3K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+3K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc.20130—
+3K122336Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill Bit) 1.8MMEleven Blade Solutions, Inc.20137—
+3K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+3K111032CMC Cable FixInstratek, Inc.20112—
+3K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+3K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical2010152
+3K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions20090—
+3K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef200929—
+3K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+3K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+3K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company20078—