510(k) Report

Devices descending from K032187

37 later devices reach Anthrex Titanium Opening Wedge Osteotomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141548High Tibial Osteotomy SystemNewclip Technics20153—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K092381Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor…Ibalance Medical, Inc.20090—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K213214Xpert WristNewclip Technics20210—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K173746Activmotion RangeNewclip Technics20181—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K241539Activmotion SNewclip Technics20240—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—