510(k) Report

Devices descending from K073624

342 later devices reach Modular Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+5K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+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—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+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—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+7K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+7K143092Tensyn PlugDallen Medical, Inc.20151—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K150359Tensyn PlugDallen Medical, Inc.20150—