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Monogram Reports 1st Fully Autonomous Saw-Based Robotic Knee Replacement

The company and Krishna Shalby Hospital partnered to evaluate the mBôs TKA system with the Consensus CKS implant’s safety and effectiveness.

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By: Sam Brusco

Associate Editor

The mBôs TKA (total knee arthroplasty) system. Photo: Monogram Technologies website.

Monogram Technologies has completed the first ever fully autonomous, saw-based robotic knee replacement surgery on a live patient. The procedure was performed at the Krishna Shalby Hospital in Ahmedabad India, as part of Monogram’s multi-center clinical trial in India for the Monogram TKA system.

The company and Shalby partnered to evaluate the mBôs TKA system with the Consensus CKS implant’s safety and effectiveness. The Consensus implant is substantially equivalent to the Monogram mPress implants for regulatory purposes.

The clinical trial includes 102 total knee replacement procedures, with a three-month clinical follow-up, conducted across multiple sites in India. Shalby founder Dr. Douglas Unis said watching the ease with which the system cut and executed the procedure was incredibly fulfilling, and the system’s safety and accuracy were on full display.

“It really was an amazing moment watching Dr. Patil realize that robots can be more than marketing gimmicks but tools that actually change how knee replacements can be done better,” Dr. Unis told the press. “Based on years of evaluating technology, watching this surgery was the final validation I needed to know with certainty that we have a groundbreaking product. It was incredible that there was so little stress, given the level of autonomy and first-time use on a living person. It was flawless.”

Monogram’s mBôs semi-autonomous TKA system earned U.S. Food and Drug Administration (FDA) 510(k) clearance in March.

“The first fully autonomous knee replacement on a live patient using Monogram’s TKA System is a tremendous milestone for the company,” said Monogram CEO Benjamin Sexson. “The procedure marks the culmination of years of hard work and dedication by our incredible team. I feel honored and proud to work with such incredible and dedicated individuals at Monogram. The system appears to have flawlessly executed the plan based on intraoperative surgeon evaluation, including intraoperative laxity estimation and achievement of planned alignment. I believe Monogram’s product will have a significant positive impact on the standard of care for orthopedic medicine in the years to come.”

Zimmer Biomet and Monogram recently announced they began an agreement for Zimmer Biomet to acquire all outstanding shares of stock of Monogram.

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