510(k) Report

Devices descending from K953877

572 later devices reach Mitek Gii Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+6K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+6K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+6K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+6K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+6K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+6K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+6K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K150359Tensyn PlugDallen Medical, Inc.20150—
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+6K133304RXG Distraction SystemKLS-Martin L.P.20140—
+6K133275Mini TightropeArthrex, Inc.201411—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+6K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+6K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+6K112437Arthrex Fracture SystemArthrex, Inc.201191—
+6K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+6K111032CMC Cable FixInstratek, Inc.20112—
+6K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+6K101484Compressyn BandDallen Medical20115—
+6K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+6K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+6K091156Trimed Sterile ProductTriMed, Inc.20090—
+6K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+6K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+6K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+6K053339Allofix AnchorMusculoskeletal Transplant Foundation20060—
+6K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+7K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+7K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+7K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+7K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+7K260018Arthrex FiberButtonArthrex, Inc.20260—
+7K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+7K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+7K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+7K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+7K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+7K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+7K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+7K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+7K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+7K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+7K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+7K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+7K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+7K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+7K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+7K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+7K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+7K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+7K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+7K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+7K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+7K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+7K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+7K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+7K220906Secure-LockXiros, Ltd.20220—
+7K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+7K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+7K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+7K212739ActiFlipParcus Medical, LLC20210—
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+7K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+7K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+7K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K202581Arthrex TightRope IIArthrex, Inc.20209—
+7K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+7K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+7K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+7K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+7K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+7K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+7K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+7K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+7K191204Infinity Fixation SystemConmed Corporation20190—
+7K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+7K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+7K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K180243Infinity-Lock Button SystemXiros, Ltd.20180—