Bioretec receives FDA 510(k) clearance for ActivaScrew Cannulated COM

Bioretec Ltd ("Bioretec" or the "Company"), a pioneer in bioabsorbable orthopedic implants, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ActivaScrew™ Cannulated COM bioabsorbable compression screw. The clearance enables the commercialization of the product in the United States in accordance with its cleared indications for use.

The clearance covers the fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts of the upper (hand, non-diaphyseal arm & forearm) and lower (foot, non-diaphyseal ankle) extremities in the presence of appropriate immobilization. ActivaScrew™ Cannulated COM is intended to be used for skeletally mature adults.

FDA 510(k) clearance is granted for medical devices when the manufacturer demonstrates that the device is substantially equivalent to a legally marketed medical device in the United States. ActivaScrew™ Cannulated COM complements Bioretec's ActivaScrew™ product portfolio. The headless design of the product allows the screw to sit fully flush with the bone, minimizing the risk of soft tissue irritation. ActivaScrew™ Cannulated COM is based on the same PLGA material as the other products in the Activa product family and utilizes the same proprietary manufacturing processes. More than half a million Activa implants have already been sold worldwide.

"FDA 510(k) clearance for ActivaScrew™ Cannulated COM marks an important step in the development of our Activa product portfolio in the United States. This approval has been part of our development and commercialization strategy for 2026. The new headless compression screw aligns our product design with surgeon preferences in the US market, enabling broader market reach." says Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec.

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries. The company's latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. Bioretec's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients. To learn more about Bioretec, visit www.bioretec.com