510(k) Report

Devices descending from K010321

200 later devices reach Modular Foot System - 2.7 MM Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+3K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K213214Xpert WristNewclip Technics20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173641Activ AnkleNewclip Technics20183—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—