In2Bones Receives FDA 510(k) Clearance for Quantum Total Ankle
In2Bones Global, Inc. today announces clearance from the U.S. Food and Drug Administration to market the Quantum™ Total Ankle.
This new total ankle replacement system treats patients who suffer from arthritis and is designed to improve patient mobility, increase stability, and technologically advance implant placement based on patient-specific anatomy.
Compared to current total ankles on the market, the anatomically designed talus with a dual radius of curvature improves the dorsi and plantar flexion of the patient. In addition, the Quantum system has a unique cruciate shaped vertical stem in the tibia to provide unsurpassed stability and fixation upon impaction.
The Quantum Total Ankle was designed with OrthoPlanify™ Patient Specific Instrumentation (PSI). Upon additional anticipated FDA clearances, it will be only the second total ankle on the market with this patient CT guided technology.
“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,” says Jon Simon, Sr. Vice President of Marketing.
With OrthoPlanify, the surgeon controls the software to easily modify, adjust, and manipulate the views in their browser. In addition to the technologically advanced software, the 3D printed guides used in surgery save multiple steps and allow for precision bone cuts, compared to the predicate’s pin placement instruments.
In2Bones is set to initiate the controlled market release of the Quantum Total Ankle this summer, with a full market launch in the first quarter of 2021.
See Full Press Release: In2Bones Receives FDA 510(k) Clearance for Quantum™ Total Ankle | Business Wire
Written by: In2Bones
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