510(k) Report

Devices descending from K040356

255 later devices reach Kompressor Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+1K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc.20132—
+1K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006251—
+2K140875Optossol Compression Device SystemGenossis, LLC20140—
+2K073159Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd.20083—
+2K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+3K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+3K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+3K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+3K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+3K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+3K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+3K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+3K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+3K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K210159IntraLock SystemFusion Orthopedics, LLC20210—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+4K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+4K172785Conquest FNSmith & Nephew20178—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K152686Conquest FNSmith & Nephew201612—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+4K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+4K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+4K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+4K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+4K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+4K124027Monster Screw SystemApogee Orthosolutions201341—
+4K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+4K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+4K102528N-Force Fixation SystemInnovision, Inc.20115—
+4K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+4K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+4K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+5K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K190586Monster® Screw SystemParagon 28, Inc.201921—
+5K182677DynaNail MiniMedShape, Inc.20195—
+5K182989AURORA™ Screw SystemMiRus, LLC20180—
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—