Monogram Orthopaedics Inc. is pleased to announce the completion of its first pre-submission meeting with the U.S. Food and Drug Administration (FDA) for its mBôs TKA System to assist surgeons in treating patients who require total knee replacement procedures. The pre-submission objectives included a system review with the FDA and obtaining feedback on our proposed regulatory pathway and nonclinical test plan. To assist the Company with this effort, the Company engaged MCRA, a leading Washington, DC-based provider of regulatory strategy and advice for orthopedic and musculoskeletal devices.
The FDA considered a number of questions related to the proposed indicated uses, nonclinical test plan, predicates, and clinical pathway. The next step will be for the Company to prepare a supplement that will provide the FDA with additional detail on the operation of certain functions of our system discussed with their panel. The Company anticipates it will submit this supplement in Q2 2023.
"This meeting was a significant regulatory milestone on our journey to bring the mBôs TKA System to market," said Benjamin Sexson, CEO of Monogram. "FDA provided a lot of valuable and thoughtful feedback on our system and clarifications that will be helpful as we progress. We appreciate the input from the panel and look forward to preparing additional documentation for review."
The Monogram robotic TKA system is a navigated cart-based robot arm designed to cut with a sagittal saw. The eventual hope in the future is to reduce surgical time and enable the next generation of 3D-printed press-fit orthopedic implants. With 20 patent filings and an aggressive development effort, the Company continues to push this mission.
"In the meeting, FDA officials provided supportive feedback related to some of the Company's underlying regulatory assumptions and strategies; for example, they concur that animal testing is likely unnecessary," said Kevin Posey, Director of Quality Assurance and Regulatory Affairs. "Monogram intends to utilize the FDA's guidance, and future expected guidance to move forward with our testing plan, 510(k) filing, and commercialization efforts."
The first-generation surgical robot will facilitate the placement of Monogram's FDA-approved mPress implant system, a press-fit total knee with improvements to FDA-approved implant designs the Company licensed in March 2020. The implants will feature an asymmetric tibia and anatomic patella options for robotic implantation or manual instrumentation.