Onkos Surgical secures FDA clearance to expand NanoCept coating across ELEOS implant system

USA—Onkos Surgical has received US Food and Drug Administration (FDA) clearance to expand the use of its NanoCept antibacterial coating across additional titanium components of its ELEOS limb salvage system, broadening the range of implants available for complex orthopaedic reconstruction.

The latest 510(k) clearance authorises NanoCept application to cemented bowed segmental stems, proximal femurs, tibial baseplates and augments.

It also allows the company to extend the coating to additional titanium components that had previously received FDA clearance.

Expanding antibacterial protection in orthopaedic implants

NanoCept is an antibacterial coating designed to reduce bacterial contamination on implant surfaces in the operating theatre before surgical insertion.

The technology targets bacteria that may come into contact with implants during surgical handling and preparation.

According to Onkos Surgical, extensive preclinical evaluations demonstrated up to a 99.9% reduction in bacteria commonly encountered in operating rooms.

However, 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 latest decision represents the fourth 510(k) clearance for NanoCept since the FDA granted its initial de novo authorization in April 2024.

It follows another clearance earlier in 2026 that expanded the technology’s application to titanium implants.

Supporting complex reconstructive procedures

Onkos Surgical founder and CEO Patrick Treacy said the clearance supports the company’s efforts to develop a broader range of antibacterial-coated implants that meet the evolving needs of orthopaedic surgeons and their patients.

The company is continuing to invest in regulatory expansion and manufacturing innovation as it seeks to address bacterial contamination, a persistent challenge in orthopaedic surgery.

To support the supply of coated implants for complex reconstructive procedures, Onkos Surgical manufactures NanoCept-coated components at its NanoCept Innovation Center in Bridgewater, New Jersey.

The expanded clearance increases the range of titanium components available with the coating within the ELEOS system, giving surgeons access to additional implant configurations for limb salvage and complex reconstruction procedures.

Sign up HERE to receive our email newsletters with the latest news and insights from Africa and around the world, and follow us on LinkedIn for updates.