SS Innovations announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its SSi Mantra surgical robotic system for general, urological, colorectal, gynecological, and cardiac surgery.

Based on a pre-submission meeting and subsequent discussions with the FDA, the company decided to chase a 510(k) submission instead of a De Novo request for SSi Mantra, aiming to benefit from the pathway’s potential speed and cost efficiencies.

“Our submission of a 510(k) premarket notification to the FDA marks an important milestone in our strategic plan to introduce the company’s advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market,” said SS Innovations chairman and CEO Dr. Sudhir Srivastava. “Given its affordability, differentiated technology, and proven performance across our existing global installations, we believe the SSi Mantra represents a highly compelling option for hospitals and surgeons in the United States, especially those serving underserved patient communities.”

Separately, the company continues along the pathway toward a EU CE marking certification it believes it could obtain in the first half of 2026. As of November 30, the SSi Mantra cumulative installed base totaled 138 systems across eight countries where the company’s surgical robotic system has earned regulatory approval. To date, 137 hospitals have installed it and over 7,300 surgical procedures have been performed, including 88 telesurgeries and 390 cardiac procedures.

Last month, SS Innovations reported the first telesurgery using its Tele Surgeon Console, a compact, self-contained, chair-based version of the larger SSi Mantra surgeon command center.