510(k) Report

Devices descending from K051908

149 later devices reach Charlotte Compression Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K143092Tensyn PlugDallen Medical, Inc.20151—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K150359Tensyn PlugDallen Medical, Inc.20150—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—