Bioretec receives FDA market authorization for RemeOs trauma screw
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Key takeaways:
- Bioretec has received FDA market authorization for its RemeOs trauma screw.
- The bioresorbable metal implant is designed to aid fixation for patients with ankle fractures.
Bioretec Ltd. has announced FDA market authorization of its RemeOs trauma screw, a bioresorbable metal implant for patients with ankle fractures, according to a company press release.
The RemeOs trauma screw had previously received FDA breakthrough device designation.
“This FDA market approval is the most important milestone in our company's history to date,” Timo Lehtonen, CEO of Bioretec, said in the release. “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 the 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,” Lehtonen added.
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