510(k) Report

Devices descending from K963420

339 later devices reach Cancellous Screw Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+6K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+6K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+6K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+6K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+6K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+6K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+6K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+6K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+6K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+6K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+6K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+6K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+7K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+7K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+7K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+7K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K202326BESPA Charcot SystemBespa Global, LLC20210—
+7K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+7K210159IntraLock SystemFusion Orthopedics, LLC20210—
+7K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K193029Conquest FNSmith & Nephew, Inc.202010—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+7K172785Conquest FNSmith & Nephew20178—
+7K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+7K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+7K152686Conquest FNSmith & Nephew201612—
+7K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+7K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+7K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+7K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+7K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+7K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+7K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+7K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+7K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+7K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+7K124027Monster Screw SystemApogee Orthosolutions201341—
+7K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+7K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+7K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+7K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+7K102528N-Force Fixation SystemInnovision, Inc.20115—
+7K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+7K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+7K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+8K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+8K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+8K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+8K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+8K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+8K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+8K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+8K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+8K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+8K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+8K191995S4 Screw SystemSubchondral Solutions, Inc.20202—