510(k) Report

Devices descending from K993106

728 later devices reach Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K191241AutoStrutOrthospin20194—
+5K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+5K182677DynaNail MiniMedShape, Inc.20195—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K182989AURORA™ Screw SystemMiRus, LLC20180—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K173883External Fixation SystemLife Spine, Inc.20180—
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+5K150871ForeFoot STP SystemTornier, Inc.20150—
+5K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+5K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+5K150626Rush Medullary PinsZimmer, Inc.20150—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+5K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+5K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+5K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+5K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+5K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+5K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+6K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+6K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+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—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—