Onkos Surgical® Receives FDA 510(k) Clearance for ELEOS™ Proximal Tibia with NanoCept® Antibacterial Technology
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.
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.
