510(k) Report

Devices descending from K033669

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K191241AutoStrutOrthospin20194—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K182989AURORA™ Screw SystemMiRus, LLC20180—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K173883External Fixation SystemLife Spine, Inc.20180—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+4K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K150871ForeFoot STP SystemTornier, Inc.20150—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+4K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+4K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+4K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+4K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+4K141992Variax 2 SystemStryker Trauma AG201422—
+4K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+5K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—