510(k) Report

Devices descending from K962397

531 later devices reach Statak Soft Tissue Attachment Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+6K220906Secure-LockXiros, Ltd.20220—
+6K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+6K220757Argo Knotless SP AnchorConmed Corporation20226—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+6K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+6K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+6K202581Arthrex TightRope IIArthrex, Inc.20209—
+6K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+6K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+6K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+6K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+6K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+6K191204Infinity Fixation SystemConmed Corporation20190—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+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—
+6K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K171725CuffLink Implant SystemConmed Corporation20170—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K171296SutureTapeArthrex, Inc.20173—
+6K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+6K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+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—
+6K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+6K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+6K143139Arthrex Fracture SystemArthrex, Inc.20151—
+6K141420FastforwardMedShape, Inc.20145—
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+6K133304RXG Distraction SystemKLS-Martin L.P.20140—
+6K140328CMC Mini TightropeArthrex, Inc.20146—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+6K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+6K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+6K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+6K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+6K101484Compressyn BandDallen Medical20115—
+6K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+6K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+6K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+6K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+6K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+6K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+6K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+6K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+6K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+7K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+7K253115Lars AcjMovmedix S.A.S.20260—
+7K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+7K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+7K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+7K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+7K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+7K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K230546SignexOsteonic Co., Ltd.20242—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+7K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+7K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+7K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+7K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+7K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+7K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+7K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+7K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+7K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+7K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+7K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+7K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+7K221354Arthrex SutureTapeArthrex, Inc.20220—
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+7K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+7K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+7K213837Arthrx Fracture PlatesArthrex, Inc.20220—