510(k) Report

Devices descending from K990776

368 later devices reach Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K173641Activ AnkleNewclip Technics20183—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K140875Optossol Compression Device SystemGenossis, LLC20140—
+5K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+5K073159Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd.20083—
+5K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+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—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+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—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K213214Xpert WristNewclip Technics20210—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+6K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+6K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+6K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+6K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+6K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+6K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+6K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+6K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+6K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+6K110658Aptus Cannulated Compression ScrewsMedartis AG201112—