PARSIPPANY, N.J., Oct. 21, 2025 /PRNewswire/ — Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, announced that it has recently received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ELEOS Proximal Tibia with NanoCept Antibacterial Technology. This marks the first 510(k) clearance for the NanoCept Antibacterial Technology since the original De Novo authorization was granted in April of 2024.
Onkos Surgical® Receives FDA 510(k) Clearance for ELEOS™ Proximal Tibia with NanoCept® Antibacterial Technology
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The NanoCept technology offers a proactive approach against intraoperative bacterial contamination, a crucial advancement in the field of orthopaedic implants. In preclinical studies supporting the original De Novo market authorization, NanoCept demonstrated up to a 99.999% (5-log reduction) kill rate of bacteria that are commonly found in the operating room environment. The orthopaedic market has shown steadily increasing case demand for the NanoCept technology since the first case took place in December 2024.
“The NanoCept Antibacterial Technology is an important addition to comprehensive bacterial contamination mitigation efforts in orthopaedic surgery,” said Steven Gitelis, MD, Director of Musculoskeletal Oncology at Rush University Medical Center and Chief Medical Officer of Onkos Surgical. “The clearance of the ELEOS Proximal Tibia with NanoCept Antibacterial Technology allows us to extend this technology to one of the most challenging anatomical sites for bone tumors and complex bone loss.”
The ELEOS Proximal Tibia with NanoCept Antibacterial Technology is part of the company’s ELEOS Limb Salvage System, which offers comprehensive reconstruction options for patients with significant bone loss due to cancer, trauma, or previous surgical procedures.
“This first post-De Novo 510(k) clearance marks a major milestone, highlighting our commitment and capability to advance NanoCept technology throughout the ELEOS implant system—and ultimately beyond,” said Patrick Treacy, CEO and Co-founder of Onkos. “We remain dedicated to supporting the surgeons we serve and the patients they treat by delivering truly innovative and differentiated technologies.”
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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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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