Bioretec Earns FDA 510(k) Clearance for ActivaScrew

Bioretec received FDA 510(k) clearance to market the 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. ActivaScrew Cannulated COM complements Bioretec's ActivaScrew product portfolio. The headless design 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. As previously announced, Bioretec continues the commercialization and development of its Activa and RemeOs product portfolios in line with its strategy. Source: Bioretec Bioretec received FDA 510(k) clearance to market the 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... Bioretec received FDA 510(k) clearance to market the 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. ActivaScrew Cannulated COM complements Bioretec's ActivaScrew product portfolio. The headless design 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. As previously announced, Bioretec continues the commercialization and development of its Activa and RemeOs product portfolios in line with its strategy. Source: Bioretec