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Bioretec Announces FDA Approval for RemeOs™ Trauma Screw

Friday, March 31, 2023

Bioretec announced receiving the market authorisation of the U.S. Food and Drug Administration (FDA) for its pioneering RemeOs™ trauma screw to be used for healing of bone fractures aligned with the clinical tria. Bioretec is the first and currently, the only medical device company to offer bioresorbable metal implants in the United States, the largest single market for orthopaedic trauma products globally.

RemeOs™ trauma screws are based on a proprietary bioactive and osteopromotive magnesium alloy introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes. Bioresorbable metals combine the surgical techniques of traditional metal implants and the patient-friendly care and benefits of last-generation bioresorbable polymer implants. The RemeOs™ trauma screw is resorbed and replaced by new bone through the body's natural healing process, eliminating the need for removal surgery as the fracture and bone are healing.

RemeOs™ supports orthopaedic clinics in achieving operational and healthcare goals, whilst strengthening the value proposition for patients suffering from ankle fractures. In comparison to other clinically used products, Bioretec's orthopaedic orthopedic implant RemeOsTM offers significant cost-savings and reduced risk of complications based on the elimination of redundant removal surgeries alone.