510(k) Report

Devices descending from K121425

53 later devices reach Ortholoc 3DI Ankle Fusion Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+1K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+1K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+1K202307Activ FuseNewclip Technics20200—
+1K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+1K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+1K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+1K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+1K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+2K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+2K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+2K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+2K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—