PARSIPPANY, N.J. – November 06, 2026 -- Onkos Surgical has received its fourth FDA 510(k) clearance for NanoCept Antibacterial Technology since the coating won De Novo authorization in April 2024, extending it to more titanium components of the ELEOS Limb Salvage System.
Clearance covers femurs, tibial baseplates and stems
The new clearance adds proximal femurs, tibial baseplates and augments, and cemented bowed segmental stems to the NanoCept portfolio. It also permits broader NanoCept coverage on titanium components that were previously cleared.
The decision follows an earlier clearance this year that applied NanoCept to titanium implants.
Preclinical tests show up to 99.999% bacterial reduction
NanoCept is a proprietary coating meant to reduce bacterial contamination of implant surfaces in the operating room before implantation. Preclinical testing has shown up to a 99.999% reduction in bacteria commonly found in operating rooms.
Dr. Johannes Plate, Director of Adult Reconstruction Research at University of Pittsburgh Medical Center, said broad antibacterial coverage matters most for patients who have had multiple procedures and already face elevated risk of periprosthetic joint infection.
Onkos expands in-house manufacturing in Bridgewater, New Jersey
Onkos has invested in additional NanoCept applications and in manufacturing capacity at its NanoCept Innovation Center in Bridgewater, New Jersey. Founder and CEO Patrick Treacy described bacterial contamination as "one of the biggest challenges in orthopaedic surgery" and said the company will keep investing in regulatory expansion and manufacturing.
Clinical benefit remains unproven in human trials
NanoCept is not intended to treat existing infections. Its clinical impact, including any prevention of infection or reduction of infection risk, has not been evaluated in human clinical trials. Onkos also flags the possibility that post-market clinical results may be inconsistent with in-vitro preclinical test results.