510(k) Report

Devices descending from K020791

336 later devices reach HBS Headless Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+5K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+5K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+5K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+5K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+5K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+5K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+5K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+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—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+6K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+6K202326BESPA Charcot SystemBespa Global, LLC20210—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210159IntraLock SystemFusion Orthopedics, LLC20210—
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+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—
+6K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K172785Conquest FNSmith & Nephew20178—
+6K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+6K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+6K152686Conquest FNSmith & Nephew201612—
+6K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+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—
+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—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+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—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+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—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+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—