CE Mark Approval for RemeOs™ Trauma Screw Product Group, featuring four product lines with over 200 individual products, drives global expansion for Bioretec

TAMPERE, Finland, Feb. 14, 2025 /PRNewswire/ -- Bioretec Ltd., a pioneer in absorbable orthopedic implants, has achieved a pivotal milestone with the successful completion of its CE mark approval process for the RemeOs™ Trauma Screw product portfolio

RemeOs™ Trauma Screws, manufactured from a proprietary magnesium alloy, represent a new generation of strong, absorbable materials that enhance surgical outcomes. This product group seamlessly integrates traditional surgical techniques with the advantages of absorbable implants, promoting patient-friendly care and greater healthcare efficiency. Notably, the osteopromotive properties of RemeOs™ Trauma Screws enhance bone growth, supporting the body’s natural processes while fracture is healing. As these screws are absorbed, they obviate the need for surgical removal, delivering a cost-effective solution that aligns with the principles of value-based healthcare. The first product in from RemeOs™ magnesium alloy technology received FDA market authorization in April 2023, and its successful introduction into the U.S. market has demonstrated excellent initial patient results during its controlled launch phase.

The CE mark approval received in January 2025 opens market access across Europe, where the product now complies with the stringent MDR (Medical Device Regulation) requirements of the European Economic Area. This comprehensive approval encompasses all product lines within the RemeOs™ group, meeting diverse surgical needs across various indications for both adult and pediatric patients. The approved indications include the treatment of epi-/metaphyseal bone fractures (osteosynthesis) and the use of fixation after osteotomies for correcting deformities or malalignments in the short bones of the midfoot and hindfoot, as well as in the long bones of the upper and lower extremities, with the exception of the forefoot and hand. Specific indications examples are corrections of midfoot deformities, all ankle fractures in adults and children, and elbow fractures in children. These indications are particularly frequent, with midfoot and ankle fractures being common in both accidental injuries and sports-related traumas, while elbow fractures are among the most common fractures treated in pediatric orthopedics

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