Onkos Surgical has secured U.S. Food and Drug Administration (FDA) De Novo approval for its antibacterial coated implants.

“Implant contamination is a growing concern to the orthopedic surgical community,” Onkos Surgical Chief Medical Officer Steven Gitelis, M.D., Endowed Professor of Orthopaedic Oncology at Rush Medical College and director of Musculoskeletal Oncology at Rush Cancer Center. “When bacteria and other microorganisms contaminate the artificial joint, it leads 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.”

Bacterial contamination of a permanent implant can have devastating health effects, particularly among vulnerable patients undergoing revision arthroplasty procedures or oncology treatment.  
 
The company presented the FDA with preclinical safety and efficacy data that showed the proprietary coating does not elute and is bactericidal, with a 99.999% (five log) kill rate in in-vitro testing of bacteria that are commonly found in the operating room.
 
“Receiving De Novo approval to market this technology represents a significant milestone for our surgeon customers and the patients they care for,” Onkos Surgical Co-Founder/CEO Patrick Treacy stated. “When it comes to implant bacterial contamination and failure, patient complications may include decreased limb function, amputation, and even death. We are proud to bring this solution to the market and we look forward to working with the regulatory agencies to expand the application of the technology across our portfolio of personalized and limb reconstructive implants. This has the potential of being one of the most important advances in orthopedic medical devices in decades.”
 
The technology’s effectiveness has not been shown in human clinical trials to prevent or reduce infection rates.
 
Onkos Surgical develops solutions for musculoskeletal oncology and complex orthopedic conditions. With its Precision Orthopaedics solutions, surgeons are better informed about patient-specific clinical challenges and can plan and implement more precise reconstructions. The firm’s personalized approach supports improved patient outcomes and experiences using the latest innovations in virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization. More than 350 U.S. academic medical institutions use Onkos Surgical Precision Orthopaedics.