, /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the U.S. Food and Drug Administration's (FDA) De Novo granting for Onkos Surgical's antibacterial coating for tumor and revision orthopedic implants.
Onkos Surgical engaged MCRA in December of 2020 to support its De Novo preparations. MCRA's Regulatory and Biocompatibility teams worked jointly to provide strategic support on the De Novo submission planning, technical information and test report review. Onkos and MCRA worked diligently to draft the initial and supplementary De Novo submissions, as well as manage FDA correspondence, interactive review questions, labeling, and finalization of the De Novo grant.
The FDA approved the implants for commercial use in . This first-of-its-kind De Novo authorization will combat bacterial contamination from the operating room environment on permanent orthopedic implants, which can have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable. In testing, the data revealed that the proprietary coating does not elute and has been proven to be bactericidal, with a 99.
999% (5 log) kill rate in testing of bacteria that are commonly found in the operating room environment. This De Novo approval further adds to MCRA's unparalleled track record of success, especiall.
