Onkos Surgical Achieves FDA Clearance for Innovative ELEOS Proximal Tibia Device

Onkos Surgical Receives FDA Clearance for ELEOS™ Proximal Tibia

Onkos Surgical, a prominent company specializing in innovative solutions for intricate orthopedic procedures, has announced a significant milestone in its commitment to advancing patient care. Recently, the company secured a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ELEOS Proximal Tibia, which is integrated with cutting-edge NanoCept Antibacterial Technology. This important achievement marks the first FDA clearance for the NanoCept technology since its original authorization in April 2024.

The Significance of NanoCept Technology

The introduction of NanoCept technology signifies a proactive and innovative approach to combatting intraoperative bacterial contamination, a critical concern in orthopedic implant procedures. In preclinical tests carried out prior to its De Novo authorization, NanoCept demonstrated impressive efficacy with a kill rate of up to 99.999% (a 5-log reduction) for the bacterium commonly found within surgical environments. Such outcomes signal a growing acceptance and demand within the orthopedic market, where the first use of NanoCept technology occurred in December 2024.

Dr. Steven Gitelis, the Director of Musculoskeletal Oncology at Rush University Medical Center and Chief Medical Officer of Onkos Surgical, voiced his thoughts on this development. He stated, "The NanoCept Antibacterial Technology is an important addition to comprehensive bacterial contamination mitigation efforts in orthopedic surgery." Dr. Gitelis further expressed excitement that the clearance of the ELEOS Proximal Tibia will allow for its applications in addressing complex bone loss and tumor cases—two of the most challenging scenarios in orthopedic surgery.

Broadening Patient Options

The ELEOS Proximal Tibia is part of Onkos Surgical’s larger ELEOS Limb Salvage System. This system provides encompassing reconstructive solutions for patients experiencing notable bone loss due to cancer, trauma, or previous surgical interventions. Patrick Treacy, CEO and Co-founder of Onkos Surgical, highlighted the significance of this clearance by stating, "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."

The advancements in technology presented by Onkos Surgical reinforce their dedication to empowering surgeons and enhancing patient care. By fostering innovation, the company aims to improve surgical outcomes and ensure a better overall experience for patients undergoing complex orthopedic procedures.

Conclusion

Onkos Surgical continues to lead the field of orthopedic surgery innovation with its cutting-edge products. While this clearance undoubtedly represents a leap forward, the effectiveness of NanoCept technology in reducing infection rates in clinical trial settings remains to be verified. Nevertheless, the firm’s ongoing commitment to providing sophisticated solutions positions it as a frontrunner in the orthopedic medical community.

For more details about Onkos Surgical and their range of products designed to enhance surgical precision and patient outcomes, visit www.onkossurgical.com/nanocept.