Bioretec received FDA approval for a new Activa product
Summary
- Bioretec received FDA 510(k) clearance for its ActivaScrew Cannulated COM, allowing its commercialization in the US.
- The approval aligns with Bioretec's strategic goals and supports growth expectations for the Activa product family, though it does not alter current estimates.
- The ActivaScrew Cannulated COM is designed to minimize soft tissue irritation and complements Bioretec's biopolymer-based product line.
- US sales growth for Activa is bolstered by new sales channels and a distribution partnership with OrthoPediatrics, enhancing market entry.
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Translation: Original published in Finnish on 9/7/2026 at 8:05 am EEST.
Bioretec announced on Saturday that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new ActivaScrew Cannulated COM compression screw. This approval pertains to the company's older Activa product series, which is based on biopolymers, and it allows the commercialization of the new screw model in the United States in accordance with its cleared indications for use. We consider the news an expected step as launching the cannulated Activa screw has been one of the company's short-term strategic goals. While the product approval supports our growth expectations for the Activa product family in the US, the news has no impact on our estimates.
Expansion of Activa portfolio supports US sales
The ActivaScrew Cannulated COM is a headless compression screw designed to sit fully flush with the bone in order to minimize soft tissue irritation. Although Bioretec’s long-term investment case and, in our view, its most significant potential for value creation rely on the new-generation metallic RemeOs product family, we believe the Activa products made from biopolymers will continue to play an important role in the company's revenue growth in the coming years.
In the United States, growth in Activa sales is supported by new sales channels, such as the distribution partnership with OrthoPediatrics. The marketing authorization that has now been obtained expands the company's product portfolio and aligns it more closely with the preferences of local surgeons, which we believe will facilitate market entry. We expect the Activa product family to continue its moderate growth in the coming years, driven by the US market, and the expansion of the product portfolio is now helping to support this trend.