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
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+7K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+7K193575Arthrex SutureTapeArthrex, Inc.20201—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+7K192984APTUS Clavicle SystemMedartis AG20206—
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K190143LARS AC Band DeviceCorin USA20191—
+7K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+7K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+7K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+7K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+7K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+7K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+7K173746Activmotion RangeNewclip Technics20181—
+7K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K171465Stryker Self-Punching ICONIXStryker20171—
+7K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+7K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+7K162198GFS UltimateParcus Medical, LLC20168—
+7K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+7K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+7K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+7K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+7K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+7K142484Sternal Closure SystemJace Medical, LLC20141—
+7K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+7K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+7K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+7K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+7K133304RXG Distraction SystemKLS-Martin L.P.20140—
+7K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+7K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+7K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+7K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+7K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+7K101484Compressyn BandDallen Medical20115—
+7K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+7K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+7K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+8K261511Xpert AnkleNewclip Technics20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254182AsterOsteonic Co., Ltd.20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+8K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+8K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+8K243469SignexOsteonic Co., Ltd.20250—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+8K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+8K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+8K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+8K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+8K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+8K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+8K241539Activmotion SNewclip Technics20240—
+8K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+8K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+8K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+8K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+8K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+8K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+8K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+8K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+8K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+8K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+8K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+8K202307Activ FuseNewclip Technics20200—
+8K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+8K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+8K191972ARIX Wrist SystemJeil Medical Corporation20190—