FDA Clears Monogram Robotic System

This determination means that Monogram may market the device, subject to the general controls provisions of the Act.

Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram. It marks the culmination of years of relentless effort, innovation, and teamwork. Bringing a new technology to market in the medical field is an immense challenge, and this milestone is a testament to the dedication and resilience of our entire team. We have navigated obstacles, refined our technology, and remained steadfast in our mission to advance orthopedic robotics. Today, we take a significant step forward.

"Securing clearance for the Monogram mBôs TKA System was a rigorous process due to the complexity and sophistication of the technology. We are particularly excited about the system's performance and its potential to advance robotics in orthopedic medicine. We believe we will have strong product-market fit and are well-positioned to make a meaningful impact.

Now that the Monogram mBôs TKA System has received FDA clearance, it opens significant opportunities for the Company both domestically and internationally. Over the coming months, Monogram will integrate recent upgrades to the cutting system and other system enhancements into the cleared mBôs TKA System to further strengthen its competitiveness. The Company is focused on initial placements with key surgeon KOLs in strategic geographies to establish clinical experience and demonstrate the system's advantages in real-world surgical settings.

Monogram aims initially to place the robot with surgeons who are key opinion leaders in strategic geographies as it establishes clinical experience and demonstrates the platform in real-world settings. It plans to integrate recent upgrades to the robot’s cutting system and other enhancements into the cleared mBôs device over the coming months.