Finnish medical device company Bioretec Ltd. announced on Friday that it has received CE mark approval for its RemeOs Trauma Screw product portfolio, enabling commercialization in the European Union and other CE mark-recognizing markets.

Approval covers all cannulated and non-cannulated designs, including RemeOs FT, RemeOs FL, RemeOs FC, and RemeOs LAG Solid, with diameters from 2.0mm to 4.0mm and lengths from 8mm to 50mm. Indications include fracture and malalignment fixations in adult and pediatric patients, excluding the hand and forefoot.

EU market approval allows Bioretec Ltd. to immediately introduce the full RemeOs Trauma Screw portfolio across Europe. Expansion into non-European CE mark-recognizing markets is now possible, alongside real-world clinical data collection. Insights gained may support broader US regulatory approvals.