Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants
Bacterial contamination of orthopaedic implants is a growing clinical challenge that burdens the healthcare system and can lead to dangerous, potentially fatal complications for patients.
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.
