MiRus Gains FDA Clearance for Molybdenum Rhenium Pedicle Screw

By Julie A. Vetalice

MiRus received FDA 510(k) clearance for Europa™, a pedicle screw made with the company's proprietary MoRe® molybdenum rhenium superalloy.

This marks the first FDA clearance of a medical device with this material. MiRus developed it to provide strength, ductility and durability surpassing the limitations of titanium, cobalt and iron based alloys. Its use may help address issues such as rod failure in spinal deformity procedures, and could enable the creation of lower profile foot and ankle implants, leading to smaller surgical exposures and lower revision rates.

Source: MiRus LLC

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory