Onkos Surgical has received FDA 510(k) clearance to expand the use of its NanoCept Antibacterial Technology across additional titanium components of its ELEOS Limb Salvage System.
The clearance, announced Nov. 6, covers proximal femurs, tibial baseplates and augments, and cemented bowed segmental stems. It also allows broader application of the antibacterial coating to previously cleared titanium components.
NanoCept is designed to reduce bacterial contamination on implant surfaces in the operating room before implantation. Preclinical testing demonstrated up to a 99.999% reduction in bacteria commonly found in operating rooms.
The clearance is the fourth for NanoCept since the technology received FDA De Novo authorization in April 2024. The company also received clearance earlier this year to apply the coating to titanium implants.
Onkos has expanded its in-house manufacturing capabilities at its NanoCept Innovation Center in Bridgewater, N.J., as it works to broaden the availability of antibacterial-coated implants for complex orthopedic reconstruction.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
