510(k) Report

Devices descending from K926384

539 later devices reach Statak & Mini-Statak Soft Tissue Attachment Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K211049Tigon Medical Button SystemTigon Medical20210—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+5K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+5K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K191426FiberTak ButtonArthrex, Inc.20190—
+5K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+5K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+5K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K173910Impress SFS SystemCable Fix Medical, LLC20180—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K171703PUMA SystemPanther Orthopedics, Inc.20180—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+5K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+5K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+5K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+5K150359Tensyn PlugDallen Medical, Inc.20150—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+5K133275Mini TightropeArthrex, Inc.201411—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+5K113109Stryker Resorbable Fixation SystemStryker20113—
+5K112437Arthrex Fracture SystemArthrex, Inc.201191—
+5K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+5K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+5K111032CMC Cable FixInstratek, Inc.20112—
+5K091156Trimed Sterile ProductTriMed, Inc.20090—
+5K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+5K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+5K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+5K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+5K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+5K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+5K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+5K053339Allofix AnchorMusculoskeletal Transplant Foundation20060—
+5K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+5K051236Resorb-X SFKLS-Martin L.P.20056—
+5K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+6K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+6K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+6K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+6K260018Arthrex FiberButtonArthrex, Inc.20260—
+6K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+6K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+6K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+6K220906Secure-LockXiros, Ltd.20220—