Onkos Surgical Earns Second FDA Clearance for its NanoCept Antibacterial Tech

The U.S. Food and Drug Administration has granted 510(k) clearance to Onkos Surgical for the use of its NanoCept Antibacterial Technology on titanium implants in the ELEOS Limb Salvage System.

The clearance significantly expands NanoCept’s availability, according to the company, and represents the product’s 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.

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

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

By applying the NanoCept Antibacterial technology to titanium, Onkos Surgical broadens access to the solution 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 an additional integrated option to address bacterial contamination of the implant surface before 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 Onkos Chief Medical Officer Dr. Steven Gitelis, director of Musculoskeletal Oncology at Rush University Medical Center.

NanoCept Antibacterial Technology is clinically 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.

Onkos Surgical’s personalized approach supports improved patient outcomes and experiences through innovations in antibacterial implant coatings, virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization. More than 350 U.S. academic medical institutions choose Onkos for its complex revision and tumor orthopedic cases. The NanoCept technology’s effectiveness has not been shown in human clinical trials to prevent or reduce infection rates.