Onkos Surgical® Receives FDA 510(k) Clearance for Application of NanoCept® Antibacterial Technology to Titanium Implants in the ELEOS™ Limb Salvage System

PARSIPPANY, N.J., June 9, 2026 /PRNewswire/ -- Onkos Surgical, a leader in innovative solutions for musculoskeletal oncology and complex orthopaedic conditions, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the application of its NanoCept Antibacterial Technology on titanium implants within the ELEOS Limb Salvage System.

This clearance greatly expands the availability of NanoCept and represents the second 510(k) clearance since the original De Novo authorization. The most recent prior 510(k) clearance in October 2025 was for the ELEOS Proximal Tibia with NanoCept Antibacterial Technology.

NanoCept-coated implants are designed to support oncology and revision patients, populations that may face elevated risk for bacterial contamination due to patient and procedural factors.

By enabling NanoCept application to titanium, Onkos Surgical broadens access to antibacterial implant technology across a wider portion of the ELEOS system. The addition of an antibacterial surface to titanium implants commonly used in limb salvage procedures provides surgeons with another integrated option intended to address bacterial contamination on the implant surface prior to implantation.

"When you treat patients with these challenging orthopedic reconstructions, you're often dealing with very complex decisions. Having NanoCept available on titanium is meaningful because it expands the antibacterial options we have in cases where every detail counts," said Dr. Steven Gitelis, Director of Musculoskeletal Oncology at Rush University Medical Center and Chief Medical Officer of Onkos Surgical.

NanoCept Antibacterial Technology is supported by extensive preclinical testing, demonstrating a reduction in bacteria commonly found in the operating room, including Staphylococcus aureus (MRSA and MSSA), Cutibacterium acnes, Escherichia coli, and Pseudomonas aeruginosa.

"Expanding NanoCept onto titanium implants represents a significant advancement in our mission to bring solutions to patients undergoing complex orthopaedic procedures," said Patrick Treacy, Founder & CEO of Onkos Surgical. "This clearance enables broader integration of our antibacterial technology into the implants surgeons already rely on for limb reconstruction."

About Onkos Surgical

Onkos Surgical is a leader in innovative solutions for complex orthopaedic conditions. With our novel product portfolio, surgeons are better informed about patient-specific clinical challenges and are able to plan and implement more precise reconstructions. Our personalized approach supports improved patient outcomes and experiences using the latest innovations in antibacterial implant coatings, virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization. More than 350 of the leading academic medical institutions in the US choose Onkos for their complex revision and tumor orthopaedic cases. The NanoCept technology's effectiveness has not been shown in human clinical trials to prevent or reduce infection rates. For more information on Onkos Surgical and its products and services, please visit www.onkossurgical.com/nanocept.

Forward Looking Statements:

Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "future," "believes," "expects," "may," "will," "should," "potential," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management's beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, the possibility that post-market clinical results may be inconsistent with the in-vitro preclinical test results. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only on the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law.

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SOURCE ONKOS SURGICAL