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FDA OKs Bioretec’s RemeOs Bioresorbable Metal Trauma Screw

First bioresorbable metal implant in the U.S. market will be used for ankle fractures.

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By: Sam Brusco

Associate Editor

Bioresorbable orthopedic implant pioneer Bioretec has gained U.S. market authorization for its RemeOs trauma screw.
 
According to the company, the RemeOs trauma screw is the first and only bioresorbable metal implant approved by the U.S. Food and Drug Administration (FDA). The approved product range and indication align with a clinical trial conducted in the ankle.
 
The RemeOs trauma screw was previously granted Breakthrough Device Designation. Bioresorbable metals combine surgical techniques of traditional metal implants and patient-friendly care and benefits of last-generation bioresorbable polymer implants making implant removal operations unnecessary.
 
“This FDA market approval is the most important milestone in our company’s history to date,” Timo Lehtonen, CEO of Bioretec told the press. “The U.S. has the world’s largest market for orthopedic implants. For the first time, that market is now offered a bioresorbable alternative to be used instead of titanium and steel implants. We are confident that RemeOs trauma screw is the best option for a large share of patients considering the care and clinical outcome and from a health economics viewpoint thanks to making an additional removal operation unnecessary. We are also excited about this approval opening a less burdensome regulatory pathway for future RemeOs product lines covering a wide array of indications.”
 
Bioretec will launch the RemeOs trauma screws in the U.S. in collaboration with several hospitals and clinical professionals specialized in ankle fractures.

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