Onkos Surgical gets FDA De Novo approval of antibacterial orthopedic implants


Onkos Surgical earned the FDA's De Novo approval for its antibacterial-coated orthopedic implants, the medtech company said April 8.

The approved implants are for orthopedic oncology and revision arthroplasty, two areas where patients are more vulnerable to infection, according to a news release. The implants underwent extensive study, and the data found Onkos' implant coating is bactericidal with a 99.999% kill rate.

"When bacteria contaminate the artificial joint, it can lead to a cascade of issues that can significantly impact the patient's health," Steven Gitelis, MD, Onkos Surgical's chief medical officer, said in the release. "The current tools in our armamentarium are simply not enough to help solve this multifactorial problem. The increasing prevalence of joint procedures underscores the importance of implementing effective strategies to address the presence of bacteria. The Onkos technology is a significant innovation and another option to help reduce local bacterial load on the implant."

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