510(k) Report

Devices descending from K964532

394 later devices reach Multitak SS Suture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+5K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K220966SinefixBAAT Medical Products B.V.20231—
+5K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+5K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+5K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+5K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+5K220906Secure-LockXiros, Ltd.20220—
+5K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K202581Arthrex TightRope IIArthrex, Inc.20209—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+5K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+5K191204Infinity Fixation SystemConmed Corporation20190—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K171296SutureTapeArthrex, Inc.20173—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+5K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+5K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+5K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K141420FastforwardMedShape, Inc.20145—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+5K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+5K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+5K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+5K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+5K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+5K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+5K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+5K053339Allofix AnchorMusculoskeletal Transplant Foundation20060—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K253115Lars AcjMovmedix S.A.S.20260—
+6K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+6K230546SignexOsteonic Co., Ltd.20242—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—