Bioretec Ltd. has secured Centers for Medicare & Medicaid Services (CMS) Transitional Pass-Through Payment (TPT) status for its RemeOs Screw LAG Solid, effective Oct. 1.

“Building on the success of Breakthrough Device Designation and FDA De Novo grant, securing CMS TPT approval represents a remarkable milestone,” Bioretec CEO Sarah van Hellenberg Hubar-Fisher said. “This recognition of the value of our product and the support to accelerate its adoption in the U.S. further empowers hospitals, surgery centers, and surgeons to utilize RemeOs, the first-of-its-kind fixation technology that supports natural healing. With this new status, Bioretec is positioned to unlock growth opportunities as we aim to transform the standard of care in orthopedic fixation.”

The approval is reflected in the October 2025 Healthcare Common Procedure Coding System (HCPCS) quarterly update, which establishes a new billing code, C1741, for absorbable anchor/screw implants. This designation makes RemeOs eligible for separate pass-through payment under both the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system, providing incremental reimbursement for Medicare patients.

RemeOs is marketed as the first and only osteopromotive absorbable metal implant for orthopedic use in the United States. Made from a proprietary magnesium alloy, RemeOs provides strong and stable fixation during healing and gradually degrades as it is replaced by bone, reducing the risks and costs associated with permanent implants and subsequent hardware removal surgeries.

Clinical investigation data with RemeOs demonstrate that 90% of patients achieved fracture consolidation by six weeks, with complete healing observed by 12 weeks. In addition, the osteopromotive properties of the implant have been shown to support bone formation at the fracture site, reducing the need for secondary surgeries and eliminating the presence of permanent metal implants.

In March 2023, the RemeOs Screw LAG Solid received U.S. Food and Drug Administration (FDA) De Novo market authorization. With CMS TPT Pass-Through approval, Bioretec has achieved a rare dual milestone reached by only a handful of medical devices—recognition by both regulators and payers as a breakthrough technology with proven clinical and economic value.

“This approval further validates RemeOs as a breakthrough in material science and clinical innovation,” Bioretec Chief Technology Officer Timo Lehtonen stated. “It represents the culmination of years of investment in world-class research, testing, and robust clinical evidence —and demonstrates our commitment to advancing faster recovery and improving outcomes for patients.”

Bioretec is a globally operating Finnish medical device pioneer striving to transform orthopedic care with fully biodegradable implant technologies. The company has built 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. RemeOs implants are absorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing.