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.
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 please visit www.onkossurgical.com/
