Bioretec Ltd. | Inside information | 5 September 2026 at 12:25 p.m. EEST
Bioretec receives FDA 510(k) clearance for its ActivaScrew™ Cannulated COM bioabsorbable compression screw
2 min read Premium comments
Bioretec Ltd (“Bioretec” or the “Company”), a pioneer in bioabsorbable orthopedic implants, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ActivaScrew™ Cannulated COM bioabsorbable compression screw.
The clearance enables the commercialization of the product in the United States in accordance with its cleared indications for use. The clearance covers the fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts of the upper (hand, non-diaphyseal arm & forearm) and lower (foot, non-diaphyseal ankle) extremities in the presence of appropriate immobilization. ActivaScrew™ Cannulated COM is intended to be used for skeletally mature adults.
FDA 510(k) clearance is granted for medical devices when the manufacturer demonstrates that the device is substantially equivalent to a legally marketed medical device in the United States.
ActivaScrew™ Cannulated COM complements Bioretec’s ActivaScrew™ product portfolio. The headless design of the product allows the screw to sit fully flush with the bone, minimizing the risk of soft tissue irritation. ActivaScrew™ Cannulated COM is based on the same PLGA material as the other products in the Activa product family and utilizes the same proprietary manufacturing processes. More than half a million Activa implants have already been sold worldwide.
“FDA 510(k) clearance for ActivaScrew™ Cannulated COM marks an important step in the development of our Activa product portfolio in the United States. This approval has been part of our development and commercialization strategy for 2026. The new headless compression screw aligns our product design with surgeon preferences in the US market, enabling broader market reach.” says Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec.
As previously announced, Bioretec continues the commercialization and development of its Activa and RemeOs™ product portfolios in line with its strategy.
For additional information:
Sarah van Hellenberg Hubar-Fisher
CEO
+31 6 1544 8736
Certified Adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025.
Bioretec’s Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.
Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.
To learn more about Bioretec, visit www.bioretec.com
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Bioretec received FDA 510(k) clearance for its ActivaScrew™ Cannulated COM bioabsorbable compression screw, enabling U.S. commercialization. This strategic approval aligns with the company's 2026 development goals, expanding its Activa product portfolio. The headless design addresses surgeon preferences, aiming to broaden market reach and strengthen Bioretec's position in the bioabsorbable orthopedic implant market.
- The clearance supports Bioretec's strategic expansion in the U.S. market for bioabsorbable orthopedic implants.
- The headless screw design is intended to enhance market adoption by meeting specific surgeon preferences.
PhD Lens: Clinical and outcomes impact
Bioretec's ActivaScrew™ Cannulated COM, a bioabsorbable compression screw, received FDA 510(k) clearance. Made from PLGA material, it features a headless design to minimize soft tissue irritation by sitting flush with bone. Indications include fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts in upper and lower extremities for skeletally mature adults, with appropriate immobilization.
- The device is constructed from PLGA, a bioabsorbable polymer, utilizing established manufacturing processes from the Activa product family.
- Its headless design is engineered to prevent soft tissue irritation by ensuring the screw is fully flush with the bone surface.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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