510(k) Report

Devices descending from K131061

15 later devices reach Restore Bunion Correction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+1K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+1K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+1K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+2K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+2K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—