510(k) Report

Devices descending from K102156

119 later devices reach Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K143092Tensyn PlugDallen Medical, Inc.20151—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K150359Tensyn PlugDallen Medical, Inc.20150—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—