FDA Approval of Bioretec’s RemeOs™ Trauma Screws Expected in April 2023

Bioretec Ltd, a leader in bioresorbable orthopedic implants, have received confirmation from the FDA that their supplement for the market authorization request for the RemeOs™ trauma screw has been received. The company is on track for a market authorization in April of 2023, with the FDA having up to 90 calendar days to make their official decision. With the supplement now filed, Bioretec has taken another step towards revolutionizing the orthopedic implant market.

Bioretec recently submitted a De Novo market authorization request for their revolutionary RemeOs™ trauma screw to the FDA in May 2022. This request marks a major milestone in the company’s journey, as the De Novo process is used when similar products have not yet received market authorization in the United States.

We’re eagerly awaiting the FDA’s decision-making process and market authorization for the RemeOs™ trauma screw in April – the final step in our hard work to bring this revolutionary approval process to fruition. Timo Lehtonen, CEO of Bioretec, is thrilled about the prospect of this exciting development.

Information about Bioretec

Bioretec is a pioneering Finnish medical device company that is revolutionizing orthopedic surgery with its bioresorbable implants. This revolutionary technology provides a unique interface between active implants and the body, stimulating bone growth and accelerating fracture healing. The products developed and manufactured by Bioretec are used around the world in over 40 countries, allowing countless patients to benefit from this innovative technology.

Bioretec is revolutionizing the orthopedic trauma industry with the launch of its new RemeOs™ product line. This innovative magnesium alloy and hybrid composite creates a new generation of strong, bioresorbable materials that eliminate the need for removal surgery while helping to heal fractures. With the potential to make titanium implants obsolete, RemeOs™ products will help clinics reach their Value-Based Healthcare targets and provide patients with more efficient healthcare. With market authorizations expected in the U.S. and Europe in 2023, Bioretec is well-positioned to disrupt the USD 7 billion global orthopedic trauma market.

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