510(k) Report

Devices descending from K060613

341 later devices reach Variax Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+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—
+6K191009Arsenal Plating SystemTrilliant Surgical20192—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+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—
+7K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+7K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+7K143092Tensyn PlugDallen Medical, Inc.20151—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+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—