510(k) Report

Devices descending from K090675

487 later devices reach Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K191636APTUS Foot SystemMedartis AG20190—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K191241AutoStrutOrthospin20194—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K173883External Fixation SystemLife Spine, Inc.20180—
+3K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K173746Activmotion RangeNewclip Technics20181—
+3K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+3K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+3K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+3K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+3K150871ForeFoot STP SystemTornier, Inc.20150—
+3K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+3K141992Variax 2 SystemStryker Trauma AG201422—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K261191Alians Elbow SNewclip Technics20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241539Activmotion SNewclip Technics20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441