510(k) Report

Devices descending from K021434

259 later devices reach Arthrex Fiberwire in Usp Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181182DYNACORD SutureMedos International SARL20181—
+1K094028CP-Fiber (Orthofiber)Cp Medical20100—
+1K091202Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying…Medshape Solutions20093—
+1K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions20094—
+1K080918Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…Depuy Mitek20080—
+1K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical2007691
+1K041553Arthrex Suture Grafting KitArthrex, Inc.200431—
+1K041894OrthofiberCp Medical20044—
+1K041589Arthrex Fiberwire with SilkArthrex, Inc.20044—
+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
+2K213046AceConnex Pre-Sutured FasciaAllosource20230—
+2K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+2K203186DYNATAPE SutureMedos International SARL20210—
+2K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+2K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation201921
+2K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+2K170957ReConnex Pre-Sutured TendonAllosource20183—
+2K172016Force Fiber Fusion SutureTeleflex Medical Incorporated20171—
+2K170642GRAVITY™ Soft Tissue Repair SystemWrightmedicaltechnologyinc20170—
+2K143356NovoStitch Plus Meniscal Repair SystemCeterix Orthopaedics, Inc.20152—
+2K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2Dunamis, LLC20150—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+2K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.201514—
+2K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+2K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+2K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc.20130—
+2K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+2K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+2K122336Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill Bit) 1.8MMEleven Blade Solutions, Inc.20137—
+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—
+2K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+2K100652Acl TightropeArthrex, Inc.201065—
+2K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical2010152
+2K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions20090—
+2K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef200929—
+2K090107Mini TightropeArthrex, Inc.200921—
+2K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+2K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+2K071796Capsew Plication SystemCayenne Medical, Inc.20070—
+2K071622Arthrex FiberwireArthrex, Inc.20073—
+2K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.200723—
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+2K052901Arthrex TensionlokArthrex, Inc.20050—
+2K050150Mani Needle & Suture PackMani, Inc.20050—
+3K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+3K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+3K260018Arthrex FiberButtonArthrex, Inc.20260—
+3K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+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—
+3K232733Mbrace CableMedacta International S.A.20240—
+3K230311HyperSutureThreadstone, LLC20234—
+3K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…Rti Surgical, Inc.20231—
+3K223822Activbraid™Embody, Inc.20230—
+3K220880Arthrex BioSutureArthrex, Inc.20220—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K211049Tigon Medical Button SystemTigon Medical20210—
+3K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+3K210675EasyWhipWinter Innovations, Inc.20211—
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K202242HS FiberRiverpoint Medical, LLC20200—
+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—
+3K190817HS FiberRiverpoint Medical20196—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K180531NovoStitch Pro Meniscal Repair SystemCeterix Orthopaedics, Inc.20181—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K173644Gazelle Polypropylene Suture and Delivery DeviceDura Tap, LLC20180—
+3K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+3K171296SutureTapeArthrex, Inc.20173—
+3K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+3K153746Dunamis Force DFX Tensile TapeDunamis, LLC20160—
+3K153307HS SutureTapeRiverpoint Medical20167—
+3K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+3K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+3K152795RiverLon (Nylon) SutureRiverpoint Medical20150—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K150584Stryker Suture TapeStryker20152—
+3K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150—
+3K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K140019Arthrex BiosutureArthrex, Inc.20141—
+3K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+3K132513Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM and 2.8MM…ArthroCare Corporation20136—
+3K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+3K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+3K112814CuffinkCayenne Medical, Inc.20120—