Monogram Orthopaedics submits formal response to FDA for TKA System submission

Monogram provided an update regarding its 510(k) premarket filing submission to the FDA for the company’s mBos TKA System. The company has completed all supplemental testing and submitted its formal response to the FDA regarding the additional information request received on September 30, 2024. The company does not currently anticipate further requests for information from the agency.