The company — which has locations in Gurugram, Haryana, India and Fort Lauderdale, Florida — said it submitted the robot on Dec. 5, 2025, seeking a range of indications. Those include general, urological, colorectal, gynecological and cardiac surgery. It opted for the 510(k) submission rather than a de novo request based on a pre-submission meeting and subsequent discussions with the FDA.
Mantra features a modular, 3D vision, open-console design with ergonomics that the company describes as superior. It engages machine learning models to improve safety and efficiency during procedures.
SS Innovations previously outlined plans for clearance in the first half of 2026. The company completed the first robotic cardiac surgeries in the Americas with the system in June, and then the first robotic telesurgery for weight loss a couple of weeks later. In September, it announced the world’s first pediatric pyeloplasty telesurgery using Mantra. Last month, the company completed the first telesurgery performed with its new Tele Surgeon Console (TSC).
The company says the FDA aims to complete 510(k) reviews within 90 days of receipt. Time to approval could go longer due to various factors, but Mantra could become the latest addition to the surgical robotic market in the U.S. in 2026, following Medtronic’s Hugo, which won approval last week. A host of companies, large and small, are seeking to compete in a soft-tissue surgical robotics market that Intuitive has dominated for decades.
(For a deep dive into the surgical robotics space, including detailed analysis and forecasts, purchase and download our roughly 100-page Medtech Market Intelligence Report.)
Separately, SS Innovations plans to pursue CE mark for Mantra, with eyes on the first half of 2026 for that milestone.
“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 Dr. Sudhir Srivastava, chair and CEO of SS Innovations. “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.”
