510(k) Report

Devices descending from K140397

31 later devices reach Paralock Plating System / Tuffnek Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+1K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+1K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+1K172886Breakaway Screw SystemParagon 2820174—
+1K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+1K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+1K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+2K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+2K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—