Onkos Surgical was granted FDA De Novo approval for its novel antibacterial-coated implants. Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.
Preclinical safety and efficacy data showed that the proprietary coating does not elute and has been proven to be bactericidal, with a 99.999% (5 log) kill rate in in-vitro testing of bacteria that are commonly found in the operating room environment.
“Receiving De Novo approval to market this technology represents a significant milestone for our surgeon customers and the patients they care for,” said Patrick Treacy, Onkos CEO and Co-founder. “When it comes to implant bacterial contamination and failure, patient complications may include decreased limb function, amputation, and increased rates of mortality. We are proud to bring this meaningful 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 market-leading personalized and limb reconstructive implants.”
Onkos Surgical was granted FDA De Novo approval for its novel antibacterial-coated implants. Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.
Preclinical safety and efficacy data showed that...
Onkos Surgical was granted FDA De Novo approval for its novel antibacterial-coated implants. Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable.
Preclinical safety and efficacy data showed that the proprietary coating does not elute and has been proven to be bactericidal, with a 99.999% (5 log) kill rate in in-vitro testing of bacteria that are commonly found in the operating room environment.
“Receiving De Novo approval to market this technology represents a significant milestone for our surgeon customers and the patients they care for,” said Patrick Treacy, Onkos CEO and Co-founder. “When it comes to implant bacterial contamination and failure, patient complications may include decreased limb function, amputation, and increased rates of mortality. We are proud to bring this meaningful 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 market-leading personalized and limb reconstructive implants.”
Copy to clipboard 
