Onkos Surgical Receives First FDA De Novo Approval for Antibacterial Coating on Implants, Assisted by MCRA

Monday, June 24, 2024

MCRA, a prominent independent Clinical Research Organization (CRO) specializing in medical devices, diagnostics, and biologics, has played a crucial role in obtaining U.S. Food and Drug Administration (FDA) De Novo approval for Onkos Surgical's innovative antibacterial coating designed for tumor and revision orthopedic implants.

Starting their collaboration in December 2020, Onkos Surgical engaged MCRA to navigate the De Novo submission process. MCRA's Regulatory and Biocompatibility teams worked closely together, providing strategic support in submission planning, technical review, and test report evaluation.

They prepared initial and supplementary submissions, managed FDA communications, including interactive review queries, finalized labeling, and secured the De Novo grant. The FDA granted commercial approval for these implants in April 2024.

This groundbreaking De Novo authorization addresses bacterial contamination in operating room environments for permanent orthopedic implants, crucial in orthopedic oncology and revision arthroplasty, where patient vulnerability is significant.

Extensive testing demonstrated the coating's non-elution and bactericidal properties, achieving a remarkable 99.999% kill rate against common operating room bacteria in in-vitro studies.

MCRA's successful track record in orthopedics, having supported over 50% of all orthopedic De Novo approvals, underscores their expertise in regulatory affairs and biocompatibility.

"Honored to contribute to Onkos Surgical's landmark De Novo approval for antibacterial coatings. This achievement highlights our dedication to navigating complex FDA reviews and ensuring the safety and efficacy of new medical technologies."

The collaborative effort with the FDA: "The De Novo authorization for our antibacterial technology marks a significant milestone in our ongoing partnership with the FDA.

Through rigorous science and engineering, we've established a robust foundation for future advancements in this field. We deeply appreciate MCRA's expert guidance in both scientific and regulatory domains."

CEO of MCRA, highlighted their commitment to client excellence: "MCRA's regulatory and biocompatibility experts consistently deliver top-tier service.

Achieving the first De Novo authorization for this antibacterial coating reinforces our mission to advance high-quality medical technologies worldwide, enhancing patient care."

MCRA and Onkos Surgical's collaboration on this pioneering De Novo approval sets a new standard in medical device innovation, promising improved patient outcomes through advanced antibacterial technology.






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