FDA Clears Onkos NanoCept Antibacterial Coating for More Titanium Parts of the ELEOS Limb Salvage System in the United States, the Coating's Fourth 510(k) Clearance
BRIDGEWATER, New Jersey — Onkos Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the use of its NanoCept antibacterial coating across additional titanium components of its ELEOS limb salvage system. The clearance authorises NanoCept application to cemented bowed segmental stems, proximal femurs, tibial baseplates and augments, and allows the coating to be extended to additional titanium components that had previously received FDA clearance.
NanoCept is an antibacterial coating designed to reduce bacterial contamination on implant surfaces in the operating theatre before surgical insertion, targeting bacteria that may come into contact with implants during surgical handling and preparation. According to the company, extensive preclinical evaluations demonstrated up to a 99.9 percent reduction in bacteria commonly encountered in operating rooms. The coating is not intended to treat established infections, and human clinical trials have not evaluated its effectiveness in preventing infections or reducing infection risk.
The decision is the fourth 510(k) clearance for NanoCept since the FDA granted its initial de novo authorization in April 2024, following another clearance earlier in 2026 that expanded the technology to titanium implants. Founder and CEO Patrick Treacy said the clearance supports the company's efforts to develop a broader range of antibacterial-coated implants. Onkos manufactures NanoCept-coated components at its NanoCept Innovation Center in Bridgewater, New Jersey.
Published by GSM · USA (original Chinese edition)
Photo: 图：髋关节置换术后X光片（资料图）。，经Wikimedia Commons。 / Photo: a postoperative hip prosthesis radiograph (file image). , via Wikimedia Commons.
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