510(k) Report

Devices descending from K012001

337 later devices reach Smartscrew through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+1K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+1K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.20041—
+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—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+2K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+2K062980ActivascrewBioretec, Ltd.20061—
+2K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063—
+2K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+3K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+3K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+3K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+3K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+3K203105Inion CompressOn ScrewInion OY20210—
+3K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+3K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+3K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+3K173910Impress SFS SystemCable Fix Medical, LLC20180—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+3K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+3K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+3K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+3K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+3K150359Tensyn PlugDallen Medical, Inc.20150—
+3K133858Tensyn BandDallen Medical, Inc.20143—
+3K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+3K131850Tensyn BandDallen Medical, Inc.20135—
+3K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+3K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K083070Toggleloc SystemBiomet Sports Medicine2008946
+3K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+3K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+3K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+4K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+4K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+4K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+4K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+4K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+4K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+4K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+4K220650TriMed Ripcord DeviceTriMed, Inc.202211
+4K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+4K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+4K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+4K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+4K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K143139Arthrex Fracture SystemArthrex, Inc.20151—
+4K141420FastforwardMedShape, Inc.20145—
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+4K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+4K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+4K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+4K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+4K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+4K090107Mini TightropeArthrex, Inc.200921—
+4K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+4K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+4K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+4K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K253115Lars AcjMovmedix S.A.S.20260—