BionicM, an innovative Japanese medical device startup, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg; its robotic prosthetic knee.
This registration marks a significant milestone in the company’s commitment to deliver its robotic prosthetic knee to the USA market in 2024 with Japanese-proven technologies.
“Having your limbs amputated severely limits your life,” says Xiaojun Sun, CEO of BionicM, and an above-knee amputee. “While prosthetic limbs have been developed, there are many new ways to improve the lives of amputees with advanced technology. This milestone of achieving our FDA registration underscores our dedication to developing state-of-the-art prosthetic solutions that have the potential to revolutionize mobility of people who have limb loss.”
“Bio Leg is a groundbreaking prosthetic knee joint which can help improve the daily activities of limb loss in transfemoral patients. We have done several trial fittings in my New York facility with very good results,” says Gary Marano, CPO, LPO and CEO of OTF Prosthetics and Orthotics in New York. “Bio Leg allows a more natural gait to walk long distances more efficiently along with stability using ramps and inclines. Another functional benefit is to provide an easier sit to stand feature giving the user a quicker and smoother transition when standing up from a chair.”
Source: Company Press Release
