FDA cleared a 510(k) putting Onkos Surgical's NanoCept antibacterial coating on more titanium components of the ELEOS limb salvage system. The additions cover proximal femurs, tibial baseplates and augments, and cemented bowed segmental stems. The clearance also widens NanoCept coverage on components cleared earlier.
NanoCept is meant to cut bacterial contamination of the implant surface in the operating room, before the implant goes in. Preclinical testing showed up to a 99.999 percent reduction in bacteria common to the OR. Onkos says the coating does not treat existing infection, and its clinical effect has not been evaluated in human trials.
NanoCept came through a De Novo in April 2024 alongside ELEOS, and Onkos counts this as the fourth 510(k) on the technology since then. A 522 postmarket surveillance study of the coated system opened earlier in 2026. The company works from Parsippany, New Jersey, and raised a $15M Series C in 2021 led by 1315 Capital.
The De Novo plus serial 510(k) pattern is a route other coating companies can copy. One hard review establishes the classification, then each component family rides a predicate instead of going back for another De Novo.