FDA grants breakthrough device designation for bioresorbable screws from Bioretec
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Bioretec Ltd. announced it received FDA breakthrough device designation of its RemeOs Screws for use in traumatology and orthopedic surgery, according to a press release.
The new products are intended for bone fractures and the correction of deformities or malalignments. Created from a bioactive alloy, the screws contain elements natural to the body, like magnesium, zinc and calcium, which help promote new bone formation. Bioretec formulated the screws as bioresorbable metal implants. The screws are also compatible with current surgical techniques, according to the release.
“The approval of the RemeOs Screw products for the U.S. FDA’s Breakthrough Devices Program is a significant step for Bioretec in our efforts to commercialize the product in the U.S.,” Bioretec CEO Timo Lehtonen said in the release. “We are excited about this possible future opportunity for us to be able to offer patients and the health care system in the U.S. a new, fully bioresorbable metal implant that will provide more effective care and improves the patient’s quality of life.”
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