Monogram Orthopaedics receives FDA response for mBos TKA system

Monogram Technologies “announced that it has received an Additional Information Request from the U.S. Food and Drug Administration on September 30, 2024, regarding its 510(k) premarket filing submission for the Company’s mBos TKA System. The Application was submitted on July 19, 2024, and passed the initial FDA Administrative Review. The FDA informed the Company that the FDA placed the Application on hold pending a complete response to the AIR. The FDA has informed the Company that the Company has 180 days from the date of the AIR to provide a complete response to the AIR or the FDA will consider the Application withdrawn.”