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In2Bones Gains FDA Clearance for Quantum Total Ankle


In2Bones entered the total ankle market with FDA 510(k) clearance to market the Quantum™ Total Ankle. Initial launch will begin in mid-2020, followed by full launch in 1Q21.

Quantum features an anatomically designed talus with a dual radius of curvature to improve the patient's dorsi and plantar flexion. The system has a cruciate shaped vertical stem in the tibia to lend stability and fixation upon impaction. The implant was designed with OrthoPlanify™ Patient Specific Instrumentation (PSI). Upon additional anticipated FDA clearances, it will be the second total ankle on the market with this patient CT-guided technology, following Wright Medical.

OrthoPlanify software allows the surgeon to modify, adjust and manipulate views in a browser. 3D-printed guides used in surgery save multiple steps and allow for precision bone cuts, compared to the predicate’s pin placement instruments.

In2Bones Quantum Total Ankle - ORTHOWORLD
Quantum Total Ankle