Monogram Technologies Inc., an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Monogram mBôs TKA 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.
“I want to personally thank Kamran Shamaei and Dr. Douglas Unis for their vision, dedication, and contributions to this achievement. Their expertise and commitment have been invaluable in bringing this technology to life. 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 commercialization, 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.”
The Monogram mBôs TKA System is designed to deliver uncompromised safety, efficiency, and accuracy in robotic-assisted total knee arthroplasty. Engineered with scalability in mind, the system is architected to eventually support multiple orthopedic applications beyond knee replacement, positioning it as a platform for future expansion. Despite the increasing role of robotics in joint reconstruction, the market remains underpenetrated and highly consolidated, leaving significant room for innovation and growth.
Monogram believes in the benefits of personalized robotic surgery, enabled by patient-specific imaging (CT-based) and accurate predictive navigation tools. We see an opportunity to be part of the ongoing adoption of robotic-assisted procedures.
“I’ve used nearly every robotic system on the market, and I truly believe the Monogram mBôs has the potential to be the best. 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,” said Dr. Douglas Unis, Founder and Chief Medical Officer of Monogram.
“Navigating a regulatory submission of this complexity is no small feat, and I’m extremely impressed by our management team’s strategic approach and execution. Bringing a system of this sophistication through clearance requires immense effort and careful planning. Monogram has achieved this with such a small, highly focused, and motivated team. The dedication and commitment to the mission that our leadership has fostered is inspiring. Now that we’re cleared, I’m confident that when surgeons experience the mBôs TKA System firsthand-especially given the responses I’ve seen in multiple live demos-they will want to use it.”
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 remains committed to a disciplined, long-term commercialization strategy and will take a measured and strategic approach to market adoption. While the orthopedic robotics market operates on a long sales cycle, this milestone significantly de-risks the platform and validates the Company’s technology, positioning Monogram for new strategic opportunities as it executes its growth strategy.
“At Monogram, we’ve built a small but incredibly dedicated and highly technical team. It has been an incredible experience working alongside such talented and motivated individuals. We run lean, but I believe our commitment is second to none. Every day, we push ourselves to develop what we hope will be the safest, fastest, and most accurate robotic system on the market,” commented Kamran Shamaei, Chief Technology Officer of Monogram.
