FDA approves bioresorbable metal implant from Bioretec

Jun 02, 2023

March 30, 2023 By Sean Whooley

Tampere, Finland-based Bioretec says the screw is the first and only bioresorbable metal implant approved by the FDA. The product’s range and indication align with a clinical trial conducted in the ankle, according to a news release.

Bioretec validated the benefits of RemeOs in clinical trials and previously received FDA breakthrough device designation. The bioresorbable metals combine surgical techniques from traditional metal implants with the benefits of last-generation bioresorbable polymer implants. These make implant removal operations redundant, Bioretec says.

Bioretec plans to launch the RemeOs trauma screws in the U.S. in collaboration with hospitals and professionals specializing in ankle fractures. The company expects sales to grow gradually as clinics gain confidence in the bioresorbable metal implant.

“This FDA market approval is the most important milestone in our company’s history to date,” said Timo Lehtonen, CEO of Bioretec.” 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.”

Filed Under: Food & Drug Administration (FDA), Implants, Metal-on-Metal, Orthopedics, Regulatory/Compliance Tagged With: Bioretec