510(k) Report

Devices descending from K792022

988 later devices reach Herbert Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083144Acumed Clavicle Screw SystemAcumed, LLC20091—
+1K081011Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30…Arex USA20081—
+1K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+1K063244Arc Surgical Bone Reduction ScrewArc Surgical, LLC20061—
+1K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+1K050924Merete Duothreadtm Bone ScrewMerete Medical GmbH20051—
+1K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+1K030706Ebi Dynafix Compression Bone ScrewEbi, L.P.200369—
+1K020791HBS Headless Bone ScrewMillennium Medical Technologies, Inc.2002336—
+1K990622Bold ScrewNew Deal, S.A.199951
+1K990019DRG Medium Screw SystemDolphin Medical Technologies, Inc.19990—
+1K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998419—
+1K972722Ultimate Compression Screw SystemOrthopedic Designs, Inc.19980—
+1K973810DRG Large Screw SystemDolphin Medical Technologies, Inc.19980—
+1K972217Orthopedic Screw SystemFerguson Medical19970—
+1K962236Scarf Thread-Head ScrewLandos, Inc.1996548—
+1K960533K3 Bone Screw SystemKinetikos Medical, Inc.199661—
+1K960537K2 Bone Screw SystemKinetikos Medical, Inc.199641—
+2K252061Distal Xtremities SystemTriMed, Inc.20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+2K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies20250—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+2K200259Headless Compression Screw SystemOsteocentric Extremities, LLC20200—
+2K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+2K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+2K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc.20143—
+2K132910Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC20134—
+2K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+2K111266Easylock OsteosystemTriMed, Inc.20110—
+2K111608Slic Screw Repair SystemAcumed, LLC20110—
+2K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+2K101030Modification to HBS Headless Bone ScrewBiopro, Inc.2010402
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+2K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+2K070617Cannulated ScrewFournitures Hospitalieres Industrie20074—
+2K070039Memometal Fixos ScrewsMemometal Technologies200784—
+2K062352FRS ScrewDePuy Orthopaedics, Inc.2006527—
+2K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+2K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041—
+2K023365Leforte System Bone ScrewJeil Medical Corporation200320—
+2K024233Kompressor Screw SystemKinetikos Medical, Inc.2003299—
+2K023022Nugen FX ScrewBionx Implants, Inc.20022—
+2K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.20022—
+2K020819Distal Radius Plating SystemBiomet, Inc.20021—
+2K013057Biocuff,C, Models 236018, 236028, 236036Bionx Implants, Inc.200179—
+2K012001SmartscrewBionx Implants, Ltd.2001337—
+2K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999413—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K211628MIS Precision Chevron Bunion SystemRelja Innovations, LLC20221—
+3K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K210159IntraLock SystemFusion Orthopedics, LLC20210—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K192744CORRIDOR Fixation SystemGlobus Medical, Inc.20192—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+3K172785Conquest FNSmith & Nephew20178—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+3K152686Conquest FNSmith & Nephew201612—
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—