510(k) Report

Devices descending from K062352

527 later devices reach FRS Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+4K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+4K141992Variax 2 SystemStryker Trauma AG201422—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+5K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+5K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241539Activmotion SNewclip Technics20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+5K213214Xpert WristNewclip Technics20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203381Dynanail Mini HybridMedShape, Inc.202141
+5K202810AutoStrut G2Orthospin, Ltd.20213—
+5K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193366T2 ICFStryker GmbH20201—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—