Bioretec Receives FDA Clearance for Bioabsorbable Screw

Bioretec Ltd., a developer of bioabsorbable orthopedic implants, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ActivaScrew™ Cannulated COM bioabsorbable compression screw. The clearance allows for the product's commercialization in the United States for its cleared indications, which include fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts in the upper extremities (hand, excluding thumb), lower extremities (excluding foot), and for vertebral fixation.

This FDA clearance represents a significant market access achievement for Bioretec, enabling the company to introduce its bioabsorbable fixation device to the U.S. market. Bioabsorbable implants offer potential advantages over traditional metal implants, as they are designed to degrade and be absorbed by the body over time. This can eliminate the need for a second surgery to remove the implant, potentially reducing patient morbidity and healthcare costs.

The company has focused on developing and manufacturing bioabsorbable orthopedic implants utilizing polymer technology. The FDA's clearance validates the technology and product for its intended orthopedic applications. Bioretec aims to provide surgeons with alternative fixation solutions.

Bioretec will now proceed with the commercial launch of the ActivaScrew™ in the United States. The company seeks to expand the availability of its bioabsorbable implant portfolio globally.