The designation covers the RemeOs™ DrillPin for fixation of bone fragments in pediatric and adult patients and for the treatment of epi-metaphyseal fractures in pediatric patients ≥2 years of age with an open growth plate, including transphyseal indications where fixation across the growth plate is clinically required.

Breakthrough Device Designation is granted to medical devices that may provide more effective treatment for life threatening or irreversibly debilitating conditions and that represent a breakthrough technology or offer significant advantages over existing approved or cleared alternatives. The designation gives Bioretec prioritized and more interactive communication with the FDA during the remaining development and review process, which is expected to support an efficient clinical and regulatory pathway for the DrillPin.

The RemeOs™ DrillPin is the third Breakthrough Device Designation granted to Bioretec by the FDA for its RemeOs™ product portfolio (Trauma Screw, 2021; Spinal Cage, 2024).