FDA approves biodegradable metal screw implant for fixing broken bones

The FDA has approved the use of a new metal screw, used to help secure and heal broken bones, that can safely dissolve within the body over time. 

In its announcement, Finnish developer Bioretec said its RemeOs inserts were the first bioresorbable metal implants to score a green light from the agency. 

Made from an alloy of magnesium, calcium and zinc—three elements widely already present in the human body—the company said the orthopedic screws do not contain any of the rare-earth metals typically found in surgical hardware.

According to Bioretec, the screws’ metallic properties allow them to have more strength, rigidity and hardness than polymer-based bioresorbable implants. This also allows them to be used effectively in heavy load-bearing applications, such as for bones in the feet or ankles.

The company’s goal is to make traditional titanium and steel implants obsolete by doing away with the need for surgeries to remove the implants, as the RemeOs screws shrink and are slowly replaced by new bone as the injury heals.

Bioretec previously received a breakthrough designation from the FDA for its RemeOs screws in March 2021, aimed at orthopedic surgeries to fix traumatic fractures and correct bone deformities. The company submitted its de novo marketing application in May of last year.

“We are excited that we can now begin to establish key collaborations with hospitals and clinical professionals specialized in ankle fractures in the U.S.,” Bioretec CEO Timo Lehtonen said in a release, adding that it helps open a door for future implants made of the RemeOs material.

In clinical testing, the company said the screws have shown the ability to help promote new bone growth, where magnesium and calcium are essential ingredients. Preclinical studies have also shown them to be suitable for pediatric patients.

Bioretec estimates the U.S. accounts for about 65% of the international market for orthopedic implants. That’s driven in part by about 5 million cases of broken bones within the country annually—with ankle fractures being among the most common, including about 3.4 million patients per year.