In2Bones Gains FDA Clearance for Quantum Total Ankle

By Julie A. Vetalice

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.

Product Labels: Ankle Replacement

Tags: 510(k) Clearance, Regulatory