Onkos Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Eleos proximal tibia with NanoCept antibacterial technology.

NanoCept technology provides a proactive approach against intraoperative bacterial contamination. In preclinical studies supporting Eleos’ original de novo market authorization, NanoCept showed up to a 5-log reduction (99.999%) kill rate of bacteria commonly found in the operating room environment.

Eleos proximal tibia with NanoCept is part of Onkos’ Eleos limb salvage system, which provides comprehensive reconstruction options for patients with significant bone loss due to cancer, trauma, or previous surgical procedures.

Steven Gitelis, MD, director of musculoskeletal oncology at Rush University Medical Center and chief medical officer of Onkos Surgical said NanoCept is an important addition to comprehensive bacterial mitigation efforts in orthopedic surgery.

“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,” Dr. Gitelis told the press.

“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, co-founder and CEO of Onkos. “We remain dedicated to supporting the surgeons we serve and the patients they treat by delivering truly innovative and differentiated technologies.”