510(k) Report

Devices descending from K930892

598 later devices reach Mitek Mini Anchor, Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+7K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+7K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+7K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+7K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+7K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+7K191204Infinity Fixation SystemConmed Corporation20190—
+7K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+7K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+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—
+7K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+7K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+7K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+7K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+7K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+7K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+7K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+7K143139Arthrex Fracture SystemArthrex, Inc.20151—
+7K141420FastforwardMedShape, Inc.20145—
+7K142484Sternal Closure SystemJace Medical, LLC20141—
+7K133304RXG Distraction SystemKLS-Martin L.P.20140—
+7K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+7K140328CMC Mini TightropeArthrex, Inc.20146—
+7K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+7K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+7K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+7K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+7K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+7K101484Compressyn BandDallen Medical20115—
+7K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+7K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+7K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+7K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+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—
+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—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+8K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+8K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+8K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+8K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+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—
+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—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+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—
+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—
+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—
+8K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+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—
+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—