510(k) Report

Devices descending from K954330

464 later devices reach Super Screw 3.5 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+1K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+1K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+1K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006310—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+2K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+2K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+2K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+2K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics20151—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K151021OsteoMed Cannulated Screw SystemOsteomed Corp.201516—
+2K140283Osteomed Extremifuse SystemOsteomed20140—
+2K130412Osteomed Extremifuse SystemOsteomed20134—
+2K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+2K111536Metasurg Digifuse ImplantMetasurg201130—
+2K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+2K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K210159IntraLock SystemFusion Orthopedics, LLC20210—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172785Conquest FNSmith & Nephew20178—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+3K152686Conquest FNSmith & Nephew201612—
+3K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+3K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+3K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141—
+3K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+3K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+3K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+3K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+3K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+3K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+3K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+3K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+3K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K124027Monster Screw SystemApogee Orthosolutions201341—
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K122959Hammer Toe ImplantTrilliant Surgical, Ltd.2012221
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+3K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—