Monogram Technologies Secures FDA Clearance for Robotic Knee Replacement System
By Thomas Yuan, Health and Medical Technology Correspondent

AUSTIN, Texas — Monogram Technologies (NASDAQ: MGRM) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its mBôs Total Knee Replacement (TKA) robotic system, marking a major milestone in the company’s push to commercialize next-generation orthopedic surgical solutions.

Designed to bring precision, safety, and efficiency to robot-assisted knee replacement surgeries, the mBôs system integrates machine learning, augmented reality, and autonomous cutting technology to deliver a personalized and streamlined surgical experience. The platform also features expansion-ready architecture, with plans to support future applications across the broader field of orthopedic surgery.

“This is a pivotal achievement for Monogram,” said CEO Ben Sexson. “FDA clearance validates the technical rigor, innovation, and collaborative drive behind our mBôs system and represents a significant step forward for robotic medical technology in orthopedics.”

Differentiated Features for Next-Gen Precision

The mBôs robotic system includes a suite of proprietary tools aimed at improving surgical outcomes and efficiency:

• Automated preoperative planning, powered by machine learning algorithms trained on large case datasets and individual surgeon preferences;

• AR-assisted registration, using fewer anatomical points to accelerate setup time;

• Accurate navigation for surgical path and bone cutting area mapping;

• Autonomous femur and tibia cutting, executed by a high-degree-of-freedom robotic arm without the need to swap instruments mid-procedure;

• Closed-loop tracking and active navigation milling, providing real-time feedback and control during surgery.

These capabilities are paired with Monogram’s mPress knee prosthesis, which is specifically engineered for compatibility with the robotic system, enabling more balanced and anatomically tailored knee replacements.

Capitalizing on an Underpenetrated Market

Monogram emphasized that the current robotic TKA market remains underpenetrated, presenting vast opportunities for technological disruption. Existing FDA-cleared competitors in the space include Think Surgical and Globus Medical, but Monogram believes its mBôs system offers superior intelligence, automation, and integration.

In the coming months, the company plans to deploy its smart bone cutting system and other enhancements to strategic hospitals and surgical centers. These early installations aim to generate clinical usage data that will guide future improvements and support broader market adoption.

Driving the Future of Orthopedic Robotics

“Due to the technical complexity and sophistication of the mBôs platform, the FDA approval process was especially rigorous,” said Sexson. “We’re confident that this system will not only meet the growing demand for advanced orthopedic treatment, but also define the new standard for robotic precision surgery in the United States and global markets.”

With the FDA’s green light, Monogram joins a small but growing group of innovators redefining orthopedic procedures through robotic systems, AI-powered surgical planning, and next-generation medical devices. As healthcare providers increasingly prioritize minimally invasive techniques and data-driven precision medicine, technologies like mBôs are expected to shape the future of joint replacement surgery, transforming outcomes for both patients and surgeons worldwide.

Source: https://news.yaozh.com/archive/45163.html