510(k) Report

Devices descending from K012945

711 later devices reach Synthes 2.4 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K261511Xpert AnkleNewclip Technics20260—
+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—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+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—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.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—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+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—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+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—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+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—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+5K213214Xpert WristNewclip Technics20210—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210159IntraLock SystemFusion Orthopedics, LLC20210—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203381Dynanail Mini HybridMedShape, Inc.202141
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202810AutoStrut G2Orthospin, Ltd.20213—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K193366T2 ICFStryker GmbH20201—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—