510(k) Report

Devices descending from K011262

547 later devices reach Modification to the Bold Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+5K173746Activmotion RangeNewclip Technics20181—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+5K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K153378Monster BITE Screw SystemParagon 28201522—
+5K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+5K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+5K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+5K150871ForeFoot STP SystemTornier, Inc.20150—
+5K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+5K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+5K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K261191Alians Elbow SNewclip Technics20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+6K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+6K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+6K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241539Activmotion SNewclip Technics20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—