Monogram Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Monogram mBôs TKA System, allowing the company to market the device under the general controls provisions of the Act.
The Monogram mBôs TKA System is intended to enhance safety, efficiency, and precision in robotic-assisted total knee arthroplasty.
Designed with future scalability, the system is expected to support a range of orthopaedic applications beyond knee replacement, positioning it for future growth.
Monogram CEO Ben Sexson said: “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 orthopaedic medicine. We believe we will have strong product-market fit and are well-positioned to make a meaningful impact.
“Advancing a system like this from concept to clearance requires perseverance and collaboration, and I’m incredibly proud of what we’ve accomplished together. We appreciate the FDA’s engagement throughout this process.
“We anticipate this clearance will open new opportunities for Monogram. As we move toward commercialisation, we will continue refining our strategy and engaging in discussions to support broader adoption. The journey has been long, but this is just the beginning.”
Monogram is committed to advancing personalised robotic surgery through patient-specific imaging and predictive navigation tools.
The company aims to contribute to the increasing adoption of robotic-assisted procedures. With FDA clearance now obtained, Monogram anticipates significant opportunities both in the US and internationally.
In the coming months, Monogram plans to incorporate recent upgrades to the cutting system and other enhancements into the approved mBôs TKA System to bolster its market position.
