SS Innovations Seeks FDA Approval for Affordable Robotic Surgery System

SS Innovations, a pioneer in surgical robotic technologies, has officially submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its SSi Mantra surgical robotic system. This innovative system is designed for a variety of surgical specialties, including general, urological, colorectal, gynecological, and cardiac surgery.

Dr. Sudhir Srivastava, the Chairman and CEO of SS Innovations, emphasized the significance of this submission, stating, “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.” He highlighted that the system’s affordability and unique technology could provide an appealing option for hospitals and surgeons, particularly those serving underserved patient communities.

The decision to pursue a 510(k) submission, rather than a De Novo request, stems from a pre-submission meeting and ongoing discussions with the FDA. This pathway is expected to offer potential speed and cost efficiencies. The FDA aims to complete reviews of 510(k) submissions within 90 days of receipt, although the timeline could extend due to factors such as the initial acceptance review and any additional information requests.

Progress in Global Markets

As of November 30, 2025, the SSi Mantra has established a cumulative installed base of 138 systems across eight countries where it has received regulatory approval. A total of 137 hospitals have adopted the system, and more than 7,300 surgical procedures have been performed using this technology, which includes 88 telesurgeries and 390 cardiac procedures.

In addition to its efforts in the United States, SS Innovations is also pursuing certification for the SSi Mantra under the European Union CE marking, which the company anticipates could be achieved in the first half of 2026. This certification will further expand the system’s reach and availability in international markets.

The advancements in the SSi Mantra reflect SS Innovations’ commitment to enhancing surgical accessibility and affordability. As the company navigates the FDA approval process, the potential impact on healthcare delivery in the U.S. remains significant, particularly in improving outcomes for patients in need of advanced surgical options.