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
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K173746Activmotion RangeNewclip Technics20181—
+3K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+3K172785Conquest FNSmith & Nephew20178—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+3K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K153379AxSOS 3TiStryker GmbH201625—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K152686Conquest FNSmith & Nephew201612—
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific20153—
+3K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+3K151418Monster Screw SystemParagon 28201527—
+3K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+3K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+3K140565Variax 2 Compression Plating SystemStryker Trauma AG20143—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K132502Variax 2 SystemStryker Trauma AG201321—
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+3K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+3K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+3K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+3K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+3K102688Merete Locking Bone Plate System IIMerete Medical GmbH20100—
+3K100721Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd.201013—
+3K100944Clavicle Locking Plate SystemNewclip Technics20109—
+3K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+3K092189Pogo ScrewFxdevices20091—
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009241—
+3K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.20070—
+3K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc.20060—
+3K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+3K060041Trimed Bone PlatesTriMed, Inc.2006263
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K250155Xpert KneeNewclip Technics20250—
+4K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K241539Activmotion SNewclip Technics20240—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—