510(k) Report

Devices descending from K003077

342 later devices reach Smartscrew Model 222006...227510 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+1K061763Arc Surgical Biotrak ScrewArc Surgical, LLC200601
+1K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+1K043176Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC20050—
+1K043142Inion Otps Biodegradable Mini Plating SystemInion, Ltd.200519—
+1K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+1K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041—
+1K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003333—
+1K023022Nugen FX ScrewBionx Implants, Inc.20022—
+1K012001SmartscrewBionx Implants, Ltd.2001337—
+2K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+2K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+2K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+2K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+2K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+2K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+2K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+2K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+2K173910Impress SFS SystemCable Fix Medical, LLC20180—
+2K171703PUMA SystemPanther Orthopedics, Inc.20180—
+2K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+2K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+2K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+2K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150359Tensyn PlugDallen Medical, Inc.20150—
+2K133858Tensyn BandDallen Medical, Inc.20143—
+2K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+2K131850Tensyn BandDallen Medical, Inc.20135—
+2K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+2K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K083070Toggleloc SystemBiomet Sports Medicine2008946
+2K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+2K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+2K062980ActivascrewBioretec, Ltd.20061—
+2K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+2K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063—
+2K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+2K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+2K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.20041—
+3K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+3K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+3K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+3K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+3K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+3K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+3K220650TriMed Ripcord DeviceTriMed, Inc.202211
+3K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K203105Inion CompressOn ScrewInion OY20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+3K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+3K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+3K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+3K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+3K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+3K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+3K143092Tensyn PlugDallen Medical, Inc.20151—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K141420FastforwardMedShape, Inc.20145—
+3K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+3K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+3K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+3K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+3K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+3K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+3K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+3K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+3K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+3K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K253115Lars AcjMovmedix S.A.S.20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—