The new clearance extends NanoCept to additional titanium components of the ELEOS system, including proximal femurs, tibial baseplates and augments, and cemented bowed segmental stems. It also permits broader NanoCept coverage on previously cleared titanium components.
This advancement builds on the FDA clearance earlier this year for the application of NanoCept to titanium implants. It marks the fourth 510(k) clearance for NanoCept since the technology’s groundbreaking De Novo authorization in April 2024 and reflects Onkos’ ongoing commitment to expand the availability of its proprietary antibacterial technology.
“Complex joint replacement surgeries and limb salvage procedures present unique challenges, particularly in patients who have undergone multiple procedures and are already at increased risk for periprosthetic joint infection,” said Dr. Johannes Plate, Director of Adult Reconstruction Research at University of Pittsburgh Medical Center. “Having antibacterial protection on a broad range of implants helps surgeons minimize the risk of bacterial contamination, specifically in this vulnerable patient population.”