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FDA Clears First Implant with Molybdenum Rhenium Superalloy

MiRus received FDA 510(k) clearance for Europa™, a pedicle screw made with the company's proprietary MoRe® molybdenum rhenium superalloy. MoRe is the first alloy cleared by FDA for use in an implant that is not based on titanium, cobalt or iron, according to the company.

MiRus developed MoRe to provide strength, ductility and durability that surpass the limitations of other alloys. MoRe’s 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.

After seeing Kornelis Poelstra, M.D., Ph.D., present research on the material in 2017, we asked him questions about the benefits of MoRe and his perceived need for material advancements.

“Molybdenum rhenium is an alloy that’s been used for a long time to make stents in cardiology. The beauty of the material is, compared to what’s commonly used in spine—cobalt-chrome, titanium and stainless steel—it has characteristics that are a lot stronger,” Dr. Poelstra said. “MoRe uses a lot less metal to achieve the same strength and durability, and is two to three times stronger and four times more durable than cobalt-chrome or titanium.”

“The thought was, ‘Where else can we use this?’ Spine seems to be the perfect world, because we put all of this hardware in people with large architecture, since it needs to have certain strength. Because of the strength, we need a lot of metal and fairly significantly-sized rods (5.5 or 6.0mm). So, with the uptick of MIS applications, if we had a material that was stronger and therefore would allow us to achieve the same thing with a lot less metal, we could make smaller implants. We’re in the infancy of seeing what this metal can do.”

Surgeons and members of industry have expressed that material advancements will bring the next wave of innovation across orthopedics. Dr. Poelstra is one of those surgeons.

“We tend to become myopic and just look at what’s in front of us. As an industry, for the past 20 years, we’ve maximized what we can get out of cobalt-chrome, titanium, stainless steel and a couple of plastics. Our industry isn’t good at looking beyond what’s available. MoRe could be a tremendous revolution for our industry, and it may not stop at MoRe. Maybe there are other, different materials we need to look at instead of just continuing to use what has worked well for 20 years. We can’t continue to stare at the table in front of us, not looking beyond.”

More about MiRus: Europa’s clearance was the first step to development and regulatory approval for future implant lines employing MoRe, including orthopedic, spine and cardiovascular applications. The company is also developing an integrated platform of pre-operative planning and risk management tools, including a navigation and robotic system.

More about Dr. Poelstra: The Founder and Director, Spine Center of Excellence, Sacred Heart Hospital, will speak on material and robotic innovation at OMTEC 2019.