510(k) Report

Devices descending from K953877

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+5K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+5K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K133858Tensyn BandDallen Medical, Inc.20143—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K131850Tensyn BandDallen Medical, Inc.20135—
+5K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+5K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+5K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+5K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+5K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+5K121606Resorb-X GKLS-Martin L.P.20130—
+5K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+5K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K112064Resorb X-GKLS-Martin L.P.20122—
+5K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+5K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+5K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+5K100652Acl TightropeArthrex, Inc.201065—
+5K092998Conmed Linvatec Intercept ImplantLinvatec Corp.20090—
+5K090107Mini TightropeArthrex, Inc.200921—
+5K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+5K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+5K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+5K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+5K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+5K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+5K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation200601
+5K052901Arthrex TensionlokArthrex, Inc.20050—
+5K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+5K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041—
+6K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+6K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+6K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+6K251134RipCordTriMed, Inc.20250—
+6K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+6K242091Bolo Button SystemFusion Orthopedics20240—
+6K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+6K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+6K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+6K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+6K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K220966SinefixBAAT Medical Products B.V.20231—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+6K220650TriMed Ripcord DeviceTriMed, Inc.202211
+6K220757Argo Knotless SP AnchorConmed Corporation20226—
+6K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+6K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+6K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+6K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+6K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+6K211049Tigon Medical Button SystemTigon Medical20210—
+6K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+6K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+6K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+6K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+6K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+6K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+6K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+6K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+6K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K191426FiberTak ButtonArthrex, Inc.20190—
+6K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+6K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+6K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+6K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+6K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+6K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+6K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+6K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+6K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+6K173910Impress SFS SystemCable Fix Medical, LLC20180—
+6K171703PUMA SystemPanther Orthopedics, Inc.20180—
+6K173278ToggleLoc SystemBiomet, Inc.20183—
+6K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+6K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+6K171725CuffLink Implant SystemConmed Corporation20170—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+6K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—