Bioretec Wins FDA Nod for Cannulated COM Bioabsorbable Compression Screw

Bioretec, a developer of bioabsorbable orthopedic implants, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its ActivaScrew cannulated COM bioabsorbable compression screw.

The clearance covers fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts in the upper and lower extremities, with appropriate immobilization. ActivaScrew Cannulated COM is indicated for skeletally mature adults.

This clearance expands Bioretec’s ActivaScrew portfolio with a headless design that sits flush with the bone to reduce soft-tissue irritation. It uses the same PLGA material and proprietary manufacturing processes as other Activa implants. Over 500,000 Activa implants have 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,” said Sarah van Hellenberg Hubar-Fisher, CEO. “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.”

Early this year, the Tampere, Finland-based company hired former Nightingale health finance chief Tuukka Paavola as its new chief financial officer (CFO). Sarah van Hellenberg Hubar-Fisher became Bioretec’s chief executive in August 2025.

The company won FDA breakthrough status for its magnesium alloy technology-based, biodegradable RemeOs DrillPin in December 2025.