510(k) Report

Devices descending from K934183

396 later devices reach Bonutti Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+5K150359Tensyn PlugDallen Medical, Inc.20150—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+5K133275Mini TightropeArthrex, Inc.201411—
+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—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+5K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+5K112437Arthrex Fracture SystemArthrex, Inc.201191—
+5K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+5K111032CMC Cable FixInstratek, Inc.20112—
+5K091156Trimed Sterile ProductTriMed, Inc.20090—
+5K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+5K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+5K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+5K053339Allofix AnchorMusculoskeletal Transplant Foundation20060—
+5K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+6K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+6K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+6K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+6K260018Arthrex FiberButtonArthrex, Inc.20260—
+6K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+6K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+6K220906Secure-LockXiros, Ltd.20220—
+6K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+6K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+6K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+6K202581Arthrex TightRope IIArthrex, Inc.20209—
+6K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+6K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+6K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+6K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+6K191204Infinity Fixation SystemConmed Corporation20190—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+6K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K171296SutureTapeArthrex, Inc.20173—
+6K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+6K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+6K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+6K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+6K143139Arthrex Fracture SystemArthrex, Inc.20151—
+6K141420FastforwardMedShape, Inc.20145—
+6K140328CMC Mini TightropeArthrex, Inc.20146—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+6K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+6K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+6K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+6K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+6K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+6K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+6K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+6K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+6K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+7K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+7K253115Lars AcjMovmedix S.A.S.20260—
+7K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+7K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—