4/14/2023
Transformation
News
Trauma screw approved as the first bioresorbable metal implant in the U.S. market
Bioretec, active in the field of bioresorbable orthopaedic implants, has received marketing approval for its RemeOs™ trauma screw in the USA. The trauma screw is the first and currently the only bioresorbable metal implant approved by the US Food and Drug Administration (FDA). The approved product range and indication are consistent with the clinical trial conducted on the ankle.
Bioresorbable metals combine the surgical techniques of traditional metal implants with the patient-friendly care and benefits of last-generation bioresorbable polymer implants. "The US has the largest market for orthopaedic implants in the world. For the first time, this market is now offered a bioresorbable alternative that can be used in place of titanium and steel implants," comments Timo Lehtonen, CEO of Bioretec. "We are confident that the RemeOs™ trauma screw is the best option for a large proportion of patients, both in terms of care and clinical outcome, as well as from a health economic perspective, as it eliminates the need for additional surgery for removal."
Bioretec will launch the RemeOs™ trauma screws in the US in collaboration with several hospitals and clinical professionals specialising in ankle fractures.
Bioretec will launch the RemeOs™ trauma screws in the US in collaboration with several hospitals and clinical professionals specialising in ankle fractures.
