In2Bones announced today that it won FDA 510(k) clearance for its Quantum Total Ankle system to replace ankles in patients with arthritis.
The Quantum Total Ankle’s creators designed it to improve mobility, increase stability and technologically advance implant placement based on patient-specific anatomy, according to a news release.
The implant features a dual radius of curvature designed to improve the dorsi and plantar flexion of the patient. It also includes a cruciate-shaped vertical stem in the tibia for stability and fixation upon impaction.
The Quantum Total Ankle includes OrthoPlanify patient-specific instrumentation, and In2Bones touts it as the second total ankle on the market with this type of technology. OrthoPlanify is designed to allow a surgeon to modify, adjust and manipulate the views and utilize 3D-printed guides in surgery for precision bone cuts.
In2Bones said it will begin a controlled market release of the Quantum Total Ankle in summer 2020, with a full market launch set for the first quarter of 2021.
“There is a huge need for innovation in PSI for the total ankle, and the benefit to the surgeon and the patient with OrthoPlanify far exceeds what’s currently available to them,” In2Bones senior VP of marketing Jon Simon said in the news release.
Original Article: (https://www.massdevice.com/in2bones-wins-fda-clearance-for-quantum-total-ankle/)