According to a press release, Bioretec Ltd. announced FDA market approval for its RemeOs trauma screws, a bioresorbable metallic implant that can be used by patients with ankle fractures.
The FDA has previously designated the RemeOs trauma screws as a breakthrough device.
“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. This market now has a bioresorbable option to replace it.