Onkos Surgical wins FDA de novo nod for antibacterial-coated orthopedic implants

Onkos Surgical this week announced it received FDA de novo approval for its antibacterial coated implants.

According to the Parsippany, N.J.-based company, bacterial contamination of a permanent implant could have devastating effects in orthopedic oncology and revision arthroplasty.

“Implant contamination is a growing concern to the orthopaedic surgical community,” Dr. Steven Gitelis, chief medical officer, said in a news release. “When bacteria contaminate the artificial joint, it can lead to a cascade of issues that can significantly impact the patient’s health. 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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