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MiRus receives FDA 510(k) clearance for pedicle screw system made with superalloy

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MiRus announced it has received FDA 510(k) approval for the Europa pedicle screw system developed with MoRe, a molybdenum rhenium superalloy.

According to a company press release, the Europa is the first FDA-approved implant with this class of material. MiRus created MoRe for medical implants. MoRe superalloy implants will reportedly result in less soft tissue disruption, a quicker recovery and better outcomes.

“FDA approval of the Europa pedicle screw system with our patented MoRe superalloy is the culmination of over 10 years of research and development,” Jay S. Yadav MD, founder and CEO of MiRus, said in the release. “Our scientists and engineers working with world-class metallurgists have created the greatest advance in medical implant material technology in at least 4 decades. The MoRe superalloy will revolutionize many aspects of the medical device industry as the first alloy approved by the FDA for use in an implant which is not based on titanium, cobalt or iron with their inherent limitations.”

Reference:

www.mirusmed.com