510(k) Report

Devices descending from K061808

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+4K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+4K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173641Activ AnkleNewclip Technics20183—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K170771VariAx 2 Foot SystemStryker GmbH20170—
+4K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K151769Anchorage 2 CP SystemStryker GmbH20150—
+4K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+4K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+4K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+4K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+4K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+4K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+4K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+5K262344Large Compression ScrewsTriMed, Inc.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261241TriMed Compression ScrewsTriMed, Inc.20260—
+5K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+5K191867ATLAS Plating SystemMiRus, LLC20200—
+5K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+6K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—