510(k) Report

Devices descending from K904436

536 later devices reach Quickanchor (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+8K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+8K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K230546SignexOsteonic Co., Ltd.20242—
+8K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+8K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+8K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+8K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+8K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+8K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+8K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+8K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+8K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+8K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+8K221354Arthrex SutureTapeArthrex, Inc.20220—
+8K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+8K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+8K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+8K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+8K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+8K212739ActiFlipParcus Medical, LLC20210—
+8K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+8K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+8K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+8K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+8K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+8K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+8K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+8K193575Arthrex SutureTapeArthrex, Inc.20201—
+8K200226RetroFixRetrofix Screws, LLC20200—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+8K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+8K192984APTUS Clavicle SystemMedartis AG20206—
+8K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+8K190143LARS AC Band DeviceCorin USA20191—
+8K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+8K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+8K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+8K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+8K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+8K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+8K173746Activmotion RangeNewclip Technics20181—
+8K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+8K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+8K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+8K162198GFS UltimateParcus Medical, LLC20168—
+8K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+8K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+8K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+8K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+8K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+8K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+8K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+8K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+8K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+8K130431Compressyn BandDallen Medical, Inc.20134—
+8K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+8K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+8K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+8K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+9K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+9K261511Xpert AnkleNewclip Technics20260—
+9K260761APTUS Clavicle System 2.8Medartis AG20260—
+9K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+9K253538TeKBrace Knotless AnchorTheramicro20260—
+9K253695LigaMendRiverpoint Medical, LLC20260—
+9K254182AsterOsteonic Co., Ltd.20260—
+9K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+9K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+9K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+9K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+9K243469SignexOsteonic Co., Ltd.20250—
+9K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+9K243988RootMend MRRRiverpoint Medical, LLC20250—
+9K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+9K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+9K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+9K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+9K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+9K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+9K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+9K241539Activmotion SNewclip Technics20240—
+9K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+9K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+9K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+9K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+9K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+9K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+9K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+9K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+9K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+9K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+9K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+9K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+9K212433Anthem Fracture SystemGlobus Medical, Inc.20217—