Onkos Surgical has secured US Food and Drug Administration (FDA) clearance to apply its NanoCept antibacterial technology to an expanded selection of titanium components within its ELEOS limb salvage system.
The regulatory decision authorises the use of the coating on cemented bowed segmental stems, proximal femurs, and tibial baseplates and augments.
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The latest clearance also permits broader NanoCept coverage across titanium components that had previously received clearance from the agency.
NanoCept is an antibacterial implant coating developed to lower surface bacterial contamination on devices inside the operating theatre prior to surgical insertion.
In extensive preclinical evaluations, the technology achieved up to a 99.9% reduction in bacteria frequently encountered in operating rooms.
The coating is not intended to treat active infections, and its clinical impact, including infection prevention or risk reduction in patients, has not been assessed in human clinical trials.
The approval marks the fourth 510(k) clearance for the technology following its initial de novo authorisation from the FDA in April 2024.
Onkos Surgical noted that the decision builds on another clearance granted earlier this year to apply NanoCept to titanium implants.
Onkos Surgical founder and CEO Patrick Treacy said: “This regulatory milestone reinforces our commitment to deliver a comprehensive antibacterial-coated implant system that can continue to evolve alongside the needs of surgeons and their patients.
“We continue to invest in both regulatory expansion and manufacturing innovation as we work to address bacterial contamination, one of the biggest challenges in orthopaedic surgery.”
To support the supply of coated implants for complex reconstructive procedures, Onkos Surgical carries out internal production at its NanoCept Innovation Center located in Bridgewater, New Jersey, US.
