Monogram Technologies received FDA 510(k) clearance for its mBôs total knee arthroplasty (TKA) system. The company designed mBôs to deliver safety, efficiency and accuracy in robotic-assisted TKA. It says it engineered mBôs with scalability in mind, with plans to eventually support more orthopedic applications.
According to Austin, Texas-based Monogram, robotic TKA remains a significantly under-penetrated space. Other players in robotic TKA with approved products include Think Surgical and Globus Medical. Monogram believes the FDA clearance opens up significant opportunities both domestically and abroad.
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The company plans to integrate recent updates to its cutting system, along with other enhancements, over the coming months. It aims to execute initial placements with key surgeons in strategic geographies to establish clinical experience.
Ben Sexson, the company’s CEO, says that the company plans to continue refining its strategy and engaging in discussions to support broader adoption as it moves toward commercialization.
“This FDA 510(k) clearance is a defining moment for Monogram,” Sexson said. “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.”
