Monogram Technologies Submits 510(k) Application for mBôs TKA System Clearance

Monogram Technologies Inc. (NASDAQ:MGRM) has submitted a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for its mBôs TKA System. The application, submitted on July 19, 2024, passed the FDA Administrative Review and is now under substantive review. A decision is expected within 90 days, though the process may be paused if additional information is required.

The 28,214-page submission represents over eight years of rigorous testing, including simulated cadaveric surgeries. CEO Ben Sexson emphasizes the milestone's significance in improving orthopedic patient care. Vice President of Regulatory Affairs at MCRA, Dave McGurl, expressed confidence in the application’s thoroughness and quality.

Recent FDA feedback and a teleconference on the system's verification test plan are considered advantageous for the 510(k) clearance. The company anticipates this submission will facilitate commercialization and marketing opportunities for the mBôs TKA System.