Bioretec has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its RemeOs™ DrillPin, based on magnesium alloy technology.
The designation applies to the DrillPin for fixation of bone fragments in both paediatric and adult patients, including the treatment of epi-metaphyseal fractures in children aged two years and older with an open growth plate.
This also covers transphyseal indications, where fixation across the growth plate is clinically required.
Breakthrough Device Designation is granted to devices that may offer more effective treatment for life-threatening or irreversibly debilitating conditions and that present significant advantages over existing approved alternatives.
The status allows Bioretec to benefit from prioritised and interactive communication with the FDA during development and review, supporting a more efficient clinical and regulatory pathway for the DrillPin.
The RemeOs™ DrillPin is the third device in Bioretec’s RemeOs™ portfolio to receive this recognition, following the Trauma Screw in 2021 and the Spinal Cage in 2024.
It should be noted that Breakthrough Device Designation does not alter the clinical evidence required, FDA marketing authorisation, or guarantee regulatory approval.
