Bioretec Ltd, a pioneer in absorbable orthopedic implants, has been granted Transitional Pass-Through Payment (TPT) status by the U.S. Centers for Medicare & Medicaid Services (CMS) for the company's RemeOsTM Trauma Screw effective October 1, 2025.

RemeOs Trauma received TPT status under the alternative pathway for devices with both Breakthrough Device Designation and FDA market authorization. The TPT payment (HCPCS billing code, C1741) provides hospitals and ambulatory surgical centers with additional reimbursement for new and innovative technologies. Its purpose is to cover the additional cost of new and innovative devices compared to existing treatments, thereby lowering the barrier for hospitals to adopt the RemeOs Trauma Screw and making it accessible to a broader patient population.

RemeOs Trauma Screw is the first and only osteopromotive absorbable metal implant for orthopedic use in the U.S., designed to enhance bone healing and gradually degrade as it is replaced by bone, reducing the risks and costs of permanent implants.

This decision on the TPT status follows the FDA De Novo authorization granted to RemeOs Trauma Screw in March 2023 and makes Bioretec one of the few companies to receive recognition from both regulators and payors for the clinical and economic value of the breakthrough technology.

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

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.  

Bioretec's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA polymer. These implants deliver secure fixation through patented innovations and naturally degrade in approximately two years, eliminating the need for costly and invasive removal surgeries while supporting optimal bone regeneration. Activa products are both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.

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. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit https://bioretec.com.