Finnish medical device company Bioretec Oy (HEL: BRETEC), which develops biodegradable orthopaedic implants, announced on Sunday that the US Food and Drug Administration had granted Breakthrough Device Designation for its magnesium alloy-based RemeOs DrillPin.

The designation covers use of the DrillPin to fix bone fragments in paediatric and adult patients, including treatment of epi-metaphyseal fractures in children aged two years and older with open growth plates, where fixation across the growth plate is required.

Breakthrough Device Designation is reserved for devices that may offer more effective treatment for life-threatening or irreversibly debilitating conditions and provides prioritised, interactive engagement with the FDA during development and review. The DrillPin is the third product in the RemeOs portfolio to receive the status, following the Trauma Screw in 2021 and the Spinal Cage in 2024. Bioretec said the designation supports an efficient clinical and regulatory pathway and builds on US reimbursement progress, including CMS pass-through status previously granted for the RemeOs Trauma Screw.

The company plans to publish an updated commercialisation strategy, product development pipeline and revised financial targets by the end of 2025.

Bioretec noted that the designation does not alter evidentiary requirements for clinical data or FDA marketing authorisation, nor does it guarantee regulatory approval.