SS Innovations Seeks FDA Approval for Mantra Robotic Surgery System

SS Innovations 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 system is designed for a range of surgical specialties, including general, urological, colorectal, gynecological, and cardiac procedures. The submission marks a significant step in the company’s strategy to introduce this innovative and cost-effective surgical technology to the United States.

Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, highlighted the importance 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 emphasized that the system’s affordability, unique technology, and successful performance in existing global installations make it a compelling 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, was made following a pre-submission meeting and discussions with the FDA. This route is expected to provide potential efficiencies in both time and cost. The FDA aims to complete reviews of 510(k) submissions within 90 days of receipt; however, approval times may extend due to factors such as acceptance reviews, requests for additional information, and the submitter’s response times.

Expansion Plans and European Certification

In parallel to its U.S. efforts, SS Innovations is progressing toward obtaining European Union CE marking certification for the SSI Mantra, which the company anticipates could be secured in the first half of 2026.

As of November 30, 2025, the SSI Mantra has reached a cumulative installed base of 138 systems across eight countries where the system has received regulatory approval. To date, 137 hospitals have integrated the SSI Mantra into their surgical practices, with over 7,300 surgical procedures performed, including 88 telesurgeries and 390 cardiac procedures.

The developments surrounding the SSI Mantra illustrate SS Innovations’ commitment to enhancing surgical precision and accessibility while addressing the growing demand for advanced robotic surgical systems. As the company moves forward with regulatory approvals, it aims to establish a significant presence in the competitive landscape of surgical robotics.