510(k) Report

Devices descending from K993762

338 later devices reach I.CO.S Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+6K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+6K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+6K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+6K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+6K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+6K213214Xpert WristNewclip Technics20210—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K202326BESPA Charcot SystemBespa Global, LLC20210—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210159IntraLock SystemFusion Orthopedics, LLC20210—
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+6K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K193029Conquest FNSmith & Nephew, Inc.202010—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+6K172785Conquest FNSmith & Nephew20178—
+6K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+6K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+6K152686Conquest FNSmith & Nephew201612—
+6K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+6K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+6K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+6K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+6K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+6K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+6K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+6K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+6K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+6K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+6K124027Monster Screw SystemApogee Orthosolutions201341—
+6K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+6K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+6K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+6K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+6K102528N-Force Fixation SystemInnovision, Inc.20115—
+6K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+6K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+6K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+7K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+7K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+7K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+7K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+7K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+7K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+7K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+7K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+7K190830TDM Screw SystemsTdm Co., Ltd.20191—
+7K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+7K182677DynaNail MiniMedShape, Inc.20195—
+7K182989AURORA™ Screw SystemMiRus, LLC20180—
+7K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+7K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—