510(k) Report

Devices descending from K904436

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+7K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+7K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+7K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+7K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+7K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+7K260018Arthrex FiberButtonArthrex, Inc.20260—
+7K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+7K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+7K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+7K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+7K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+7K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+7K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+7K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K233659Suture WingOsteonic Co., Ltd.20230—
+7K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+7K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+7K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+7K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+7K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+7K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+7K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+7K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+7K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+7K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+7K220906Secure-LockXiros, Ltd.20220—
+7K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+7K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+7K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+7K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+7K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+7K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+7K202581Arthrex TightRope IIArthrex, Inc.20209—
+7K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+7K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+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—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+7K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+7K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+7K172921Stryker Self-Punching ICONIXStryker20170—
+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—
+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—
+7K140328CMC Mini TightropeArthrex, Inc.20146—
+7K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+7K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+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—