The clearance covers fixation of bone and osteochondral fractures, osteotomies, arthrodeses and bone grafts in the upper extremities (hand, non-diaphyseal arm and forearm) and lower extremities (foot, non-diaphyseal ankle) in skeletally mature adults. The screw’s headless design allows it to sit flush with the bone, reducing the risk of soft tissue irritation, and is built on the same proprietary PLGA material and manufacturing process as the rest of the Activa family — a product line that has now sold more than half a million implants worldwide.

The clearance was part of Bioretec’s planned 2026 development and commercialization strategy, aligning the screw’s design with surgeon preferences in the US market.

“FDA 510(k) clearance for ActivaScrew™ Cannulated COM marks an important step in the development of our Activa product portfolio in the United States. […] 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, Bioretec.