Based on the potential benefits found in various clinical studies, the FDA had designated the RemeOs trauma screw as a breakthrough device
RemeOs trauma screws are intended for bone fracture fixation and deformity correction. (Credit: Nino Liverani on Unsplash)
Finnish medical device company Bioretec has obtained market authorisation from the US Food and Drug Administration (FDA) for its RemeOs trauma screw in the US.
Based on a magnesium alloy and hybrid composite, the RemeOs trauma screw is claimed as the first and only available FDA-approved bioresorbable metal implant.
Bioretec, which is engaged in the production of bioresorbable orthopaedic implants, said that the authorised product range and indication match with the clinical trial carried out in the ankle.
Based on the potential benefits found in various clinical studies, the FDA designated the RemeOs trauma screw as a breakthrough device in 2021 for use in orthopaedic surgeries for bone fracture fixation (osteosynthesis) and deformity correction (osteotomy).
The medical device firm said that the RemeOs implants replace the need for implant removal procedures as they are resorbed and replaced by bone.
Bioresorbable metals integrate the surgical methods of conventional metal implants with the patient-friendly care and benefits brought by the latest generation of bioresorbable polymer implants. This helps enhance the surgical outcomes and facilitates fracture healing, said the company.
Bioretec CEO Timo Lehtonen said: “This FDA market approval is the most important milestone in our company’s history to date.
“The US has the world’s largest market for orthopaedic implants. For the first time, that market is now offered a bioresorbable alternative to be used instead of titanium and steel implants.
“We are confident that RemeOs trauma screw is the best option for a large share of patients considering the care and clinical outcome and from a health economics viewpoint thanks to making an additional removal operation unnecessary.”
The Finnish company will introduce the RemeOs trauma screws in the US market in partnership with hospitals and medical specialists with expertise in ankle fractures.