510(k) Report

Devices descending from K050636

544 later devices reach Synthes 3.0MM Headless Compression Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+4K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+4K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K191241AutoStrutOrthospin20194—
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182989AURORA™ Screw SystemMiRus, LLC20180—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K173883External Fixation SystemLife Spine, Inc.20180—
+4K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+4K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K173746Activmotion RangeNewclip Technics20181—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K150871ForeFoot STP SystemTornier, Inc.20150—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+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—
+4K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+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—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+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—
+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—
+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—
+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—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—