510(k) Report

Devices descending from K061808

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+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—
+3K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+3K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+3K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+3K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+3K153379AxSOS 3TiStryker GmbH201625—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+3K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K141905Pro-Link Wedge SystemLife Spine201411—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+3K141992Variax 2 SystemStryker Trauma AG201422—
+3K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+3K1334371ST MTP PlateOsteomed20132—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132642Locking Plate SystemBeijing Libeier Bio-Engineering Institute Co., Ltd.20130—
+3K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+3K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+3K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+3K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+3K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+3K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+3K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+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—
+4K261191Alians Elbow SNewclip Technics20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+4K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+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—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+4K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K211843PolyLock Plating SystemFusion Orthopedics20220—
+4K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+4K213214Xpert WristNewclip Technics20210—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—