510(k) Report

Devices descending from K100618

339 later devices reach Maxlock Extreme Extremity Plating System with Variable Angle Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+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—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K143092Tensyn PlugDallen Medical, Inc.20151—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K150359Tensyn PlugDallen Medical, Inc.20150—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—