510(k) Report

Devices descending from K953877

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K171465Stryker Self-Punching ICONIXStryker20171—
+7K171296SutureTapeArthrex, Inc.20173—
+7K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+7K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+7K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+7K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+7K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+7K143139Arthrex Fracture SystemArthrex, Inc.20151—
+7K141420FastforwardMedShape, Inc.20145—
+7K140328CMC Mini TightropeArthrex, Inc.20146—
+7K130431Compressyn BandDallen Medical, Inc.20134—
+7K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+7K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+7K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+7K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+7K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+7K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+7K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+7K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+7K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+7K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+7K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+7K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+8K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+8K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+8K253115Lars AcjMovmedix S.A.S.20260—
+8K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+8K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+8K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+8K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+8K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+8K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+8K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+8K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+8K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+8K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+8K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+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—
+8K230546SignexOsteonic Co., Ltd.20242—
+8K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+8K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+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—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+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—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+8K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+8K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+8K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+8K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+8K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+8K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+8K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+8K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+8K193575Arthrex SutureTapeArthrex, Inc.20201—
+8K200226RetroFixRetrofix Screws, LLC20200—
+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—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+8K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+8K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+8K173746Activmotion RangeNewclip Technics20181—
+8K172921Stryker Self-Punching ICONIXStryker20170—
+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
+8K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+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—