Monogram Technologies, an artificial intelligence (AI)-driven robotics company with initial focus on orthopedic surgery, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Monogram mBôs TKA (total knee arthroplasty) system.

The system is meant to deliver safety, efficiency, and accuracy in robotic total knee replacement. It’s also architected to eventually support orthopedic applications beyond knee replacement, posing it as a platform for future expansion.

“This FDA 510(k) clearance is a defining moment for Monogram,” said Monogram CEO Ben Sexson. “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.

The company touts the benefits of personalized robotic surgery enabled by CT-based, patient-specific imaging and accurate predictive navigation tools. The company said it sees an opportunity to be part of the ongoing adoption of robotic-assisted procedures.

The mBôs precision robotic surgical system autonomously executes optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced, better-fitting bone sparing knee replacements.

“I’ve used nearly every robotic system on the market, and I truly believe the Monogram mBôs has the potential to be the best,” said Monogram founder and chief medical officer Dr. Douglas Unis. “It’s slick. The precision, efficiency, versatility, and safety considerations set it apart from anything I’ve seen. I’m incredibly impressed and confident that surgeons will recognize the impact of this system.”

The company said it will integrate recent upgrades to the cutting system and other system enhancements into mBôs over the coming months.