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Onkos Surgical Advances NanoCept Technology with New FDA Clearance

On November 6, 2026, Onkos Surgical, Inc. announced the acquisition of a new 510(k) clearance from the FDA for its innovative NanoCept® Antibacterial Technology. This cutting-edge advancement is aimed at broadening the application of antibacterial treatment to include a wider range of titanium components within the company’s ELEOS™ Limb Salvage System. This achievement signifies yet another critical milestone in the ongoing commitment of Onkos Surgical to enhance antibacterial innovations in surgical procedures.

The recent FDA clearance expands the scope of NanoCept to additional titanium components of the ELEOS system, which includes proximal femurs, tibial baseplates and augments, as well as cemented bowed segmental stems. Moreover, it allows for enhanced antibacterial coverage on previously cleared titanium components. This advancement builds upon earlier FDA clearance obtained this year, underscoring a series of important protections aimed at minimizing the risks associated with periprosthetic joint infections—especially critical in patients who have undergone multiple surgical interventions.

Dr. Johannes Plate, Director of Adult Reconstruction Research at the University of Pittsburgh Medical Center, commented on the significance of this technology for complex joint replacement surgeries. He noted, “Surgical procedures involving joint replacements and limb salvage come with complex challenges, particularly in patients with a history of multiple surgeries. The introduction of antibacterial protection across a wide array of implants significantly aids surgeons in reducing the likelihood of bacterial contamination, especially for this vulnerable patient category.”

At the heart of NanoCept is a proprietary antibacterial implant coating, meticulously designed to diminish bacterial contamination on implant surfaces in the operating room prior to implantation. Robust preclinical testing has revealed remarkable results, demonstrating a reduction of up to 99.999% in bacteria commonly found in surgical environments. This remarkable efficacy is crucial for ensuring patient safety and improving surgical outcomes.

Since the technology's initial introduction, Onkos Surgical has continued to invest significantly in the development of NanoCept, enhancing its applications and bolstering in-house manufacturing capabilities at its NanoCept Innovation Center located in Bridgewater, New Jersey. These strategic investments align with the company’s long-term vision of broadening access to antibacterial-coated implants for patients facing complex orthopedic reconstructions.

Patrick Treacy, the Founder and CEO of Onkos Surgical, reiterated the company’s dedication to innovation, stating, “This pivotal regulatory accomplishment reinforces our commitment to delivering a comprehensive antibacterial-coated implant system that adapts and evolves alongside the clinical needs of surgeons and their patients.” He added, “Our ongoing investment in regulatory advancements and manufacturing innovation reflects our intent to tackle bacterial contamination, one of the most pressing challenges that accompany orthopedic surgical procedures.”

About NanoCept

NanoCept® received its De Novo market authorization from the FDA in April 2024, aimed at reducing bacterial contamination ahead of implantation due to the environmental risks present in operating rooms. It’s vital to note that NanoCept is not intended to address existing infections; thus, its clinical impact, including infection prevention or risk reduction, has yet to undergo evaluation in human clinical trials.

Forward-Looking Statements

It's essential to approach the aforementioned developments as forward-looking statements, containing inherent risks and uncertainties that might influence the actual outcomes, performance, or achievements of the company, diverging from historical trends or future projections outlined herein. Although management’s beliefs and expectations seem reasonable, actual future performance should not be unequivocally relied upon as a guarantee of success. The company assumes no obligation to update any forward-looking statements released.

For more information, please reach out to:
Gordon Ballard
Senior Vice President, Operations and Human Resources
Onkos Surgical
Email: [Email]
Phone: 201.274.6296

This release is a significant reminder of the pathways through which Onkos Surgical continues to lead the charge in the field of orthopedic advancements, ensuring patient safety and revolutionary solutions in surgical practice.