510(k) Report

Devices descending from K012923

260 later devices reach Arthrex Fiberwire, Usp Size 5, Model AR-7201 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202581Arthrex TightRope IIArthrex, Inc.20209—
+4K202242HS FiberRiverpoint Medical, LLC20200—
+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
+4K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+4K112814CuffinkCayenne Medical, Inc.20120—
+4K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+4K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+4K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+4K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+5K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+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—
+5K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+5K234079HyperSuture Extension LineThreadstone, LLC20240—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K231163HS Fiber SuturesRiverpoint Medical20243—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+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—
+5K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+5K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+5K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)Ceterix Orthopaedics, Inc.20180—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K162198GFS UltimateParcus Medical, LLC20168—
+5K162310XBraid TT Suture TapeStryker20161—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+5K133727Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and…ArthroCare Corporation20145—