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April 08, 2024
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Onkos Surgical receives FDA de novo approval of antibacterial implant coating

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Key takeaways:

  • Onkos Surgical received FDA de novo approval of its antibacterial implant coating.
  • The antibacterial coating is designed for use in orthopedic oncology, trauma and revision arthroplasty procedures.

Onkos Surgical announced FDA de novo approval of its antibacterial implant coating for use in orthopedic oncology, trauma and revision arthroplasty procedures, according to a company press release.

The antibacterial coating, which is designed for orthopedic implants, may reduce the potential for complications from bacterial contamination in patients undergoing orthopedic surgery, according to Steven Gitelis, MD, Endowed Professor of Orthopaedic Oncology at Rush Medical College and Director of Musculoskeletal Oncology at RushCancer Center.

Generic FDA News infographic
Onkos Surgical received FDA de novo approval of its antibacterial implant coating.

Gitelis noted the importance of addressing the potential of bacterial contamination in artificial joint procedures in orthopedics.

Steven Gitelis
Steven Gitelis

“Implant contamination is a growing concern to the orthopedic surgical community. When bacteria contaminate the artificial joint, it can lead to a cascade of issues that can significantly impact the patient’s health,” Gitelis told Healio. “The current tools in our armamentarium are simply not enough to help solve this multifactorial problem.”

“The Onkos technology is a significant innovation and another option to help reduce local bacterial load on the implant,” Gitelis concluded.