510(k) Report

Devices descending from K061808

410 later devices reach Darco Locking Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221395Footmotion Plating SystemNewclip Technics20220—
+1K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+1K171852DARCO Locking Bone Plate SystemWrightmedicaltechnologyinc20172—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+1K153340Epic Extremity Plate SystemEpic Extremity, LLC201632
+1K150520DARCO Locking Bone Plate SystemWrightmedicaltechnologyinc20152—
+1K142121Valor Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc20144—
+1K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+1K140876View Plating System,Reduce Fracture Plating System,Bone ScrewIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic2014215
+1K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+1K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+1K120359Ortholoc 3DI Hallux SystemWrightmedicaltechnologyinc2012842
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+1K102201Contours Lapidus Plating SystemOrthofix, Inc.20100—
+1K102688Merete Locking Bone Plate System IIMerete Medical GmbH20100—
+1K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+1K092528Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp)201053—
+1K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009241—
+1K083447Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Memometal Technologies200992—
+1K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256—
+1K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+1K071105Osteomed Calcaneal Plate and Screw Fixation SystemOsteomed LP20079—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K213567Medline UNITE Calcaneal Fracture Plating SystemMedline Industries, LP20221—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+2K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+2K190388RIVAL View Plating Systems and Reduce Fracture Plating SystemsOrthofix Srl20190—
+2K190670ORTHOLOC™ 2 Lapidus with Rotation SystemWrightmedicaltechnologyinc20190—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K172148Anchorage Bone Plating SystemStryker GmbH20184—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172441EPIC Extremity Fracture Plate SystemEpic Extremity, LLC20171—
+2K171510Footmotion Plating SystemNewclip Technics20171—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+2K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K161448Footmotion Plating SystemNewclip Technics20165—
+2K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+2K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+2K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+2K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+2K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+2K151277Airlock® osteosynthesis plate systemNovastep20152—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+2K142581APTUS Foot SystemMedartis AG201522—
+2K143523Airlock osteosynthesis plate systemNovastep20154—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+2K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+2K142135Reduce Fracture Plating System Line ExtensionIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic201405
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K140376Variax 2 SystemStryker Trauma AG201423—
+2K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K131445Osteomed Extremilock Foot Plating SystemOsteomed LP20138—
+2K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+2K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+2K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+2K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+2K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+2K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+2K100721Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd.201013—
+2K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+2K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+2K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—