Bioretec Receives FDA 510(k) Clearance for ActivaScrew Cannulated COM Bioabsorbable Compression Screw
核心洞察
Bioretec Ltd (搜索) received FDA 510(k) clearance for its ActivaScrew Cannulated COM (搜索) bioabsorbable compression screw, enabling U.S. commercialization.
The clearance covers fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts in upper and lower extremities of skeletally mature adults.
The headless design allows the screw to sit flush with bone, minimizing soft tissue irritation, and is based on the same PLGA (搜索) material as the Activa product family.
Bioretec Ltd (搜索), a Finnish pioneer in bioabsorbable orthopedic implants, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ActivaScrew Cannulated COM (搜索) bioabsorbable compression screw. The clearance, announced September 8, 2026, enables 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 extremities (hand, non-diaphyseal arm and forearm) and lower extremities (foot, non-diaphyseal ankle) in the presence of appropriate immobilization. ActivaScrew Cannulated COM (搜索) is intended for use in 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.
Product Design and Portfolio Expansion
ActivaScrew Cannulated COM (搜索) complements Bioretec's existing 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. The device is based on the same PLGA (搜索) 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 (搜索) 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," said Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec.
Company Background and Technology Platforms
Bioretec is a globally operating Finnish medical device company focused on transforming orthopedic care with fully biodegradable implant technologies. The company has built competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. Its products are used worldwide in approximately 40 countries.
The company's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA (搜索), both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.
Bioretec's latest innovation, the RemeOs (搜索) 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. The RemeOs implants are absorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and CE mark approval in Europe was received in January 2025.
As previously announced, Bioretec continues the commercialization and development of its Activa and RemeOs (搜索) product portfolios in line with its strategy.