Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants
PARSIPPANY, N.J., April 8, 2024 /PRNewswire/ -- Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a 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.
- PARSIPPANY, N.J., April 8, 2024 /PRNewswire/ -- Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a 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.
- "Implant contamination is a growing concern to the orthopaedic surgical community," said Steven Gitelis, MD, Onkos Surgical Chief Medical Officer, Rush Medical College, Endowed Professor of Orthopaedic Oncology and Director, Musculoskeletal Oncology at Rush Cancer Center.
- The Onkos technology is a significant innovation and another option to help reduce local bacterial load on the implant."