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
+3K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.200723—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+4K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+4K253145Pre-Sutured TendonRti Surgical, Inc.20250—
+4K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K232733Mbrace CableMedacta International S.A.20240—
+4K230311HyperSutureThreadstone, LLC20234—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K221354Arthrex SutureTapeArthrex, Inc.20220—
+4K220906Secure-LockXiros, Ltd.20220—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K210675EasyWhipWinter Innovations, Inc.20211—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202581Arthrex TightRope IIArthrex, Inc.20209—
+4K202242HS FiberRiverpoint Medical, LLC20200—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K193575Arthrex SutureTapeArthrex, Inc.20201—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K191204Infinity Fixation SystemConmed Corporation20190—
+4K190817HS FiberRiverpoint Medical20196—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K180531NovoStitch Pro Meniscal Repair SystemCeterix Orthopaedics, Inc.20181—
+4K173644Gazelle Polypropylene Suture and Delivery DeviceDura Tap, LLC20180—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K153746Dunamis Force DFX Tensile TapeDunamis, LLC20160—
+4K153307HS SutureTapeRiverpoint Medical20167—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K152795RiverLon (Nylon) SutureRiverpoint Medical20150—
+4K150584Stryker Suture TapeStryker20152—
+4K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+4K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+4K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150—
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140328CMC Mini TightropeArthrex, Inc.20146—
+4K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+4K132513Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM and 2.8MM…ArthroCare Corporation20136—
+4K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120—
+4K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120—
+4K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+4K112814CuffinkCayenne Medical, Inc.20120—
+4K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+4K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+4K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+4K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+4K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+4K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K253024ProZip Knotless ImplantRiverpoint Medical20250—
+5K251134RipCordTriMed, Inc.20250—
+5K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+5K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+5K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+5K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+5K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+5K234079HyperSuture Extension LineThreadstone, LLC20240—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K231163HS Fiber SuturesRiverpoint Medical20243—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+5K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+5K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—