MedTech Startup Files FDA 510(k) for Homegrown Surgical Robot SSIMantra
New Delhi: Indian medtech company SS Innovations, maker of surgical robot SSIMantra has moved ahead to become emblem of affordability and accessibility on global stage. With this end in view, MedTech Startup Files FDA 510(k) for Homegrown Surgical Robot SSIMantra. It is being looked at as a major leap for indigenous Medtech. FDA clearance to SSIMantra will enhance affordability and accessibility of robotic surgery in US healthcare too as it is doing in India.
SS Innovations International, Inc. (Nasdaq: SSII), India’s homegrown surgical robotics pioneer, reached a landmark milestone with the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the company’s next-generation SSiMantra surgical robotic system. The submission, completed on December 5, 2025, covers multiple high-demand surgical specialties, including general, urological, colorectal, gynaecological, and cardiac procedures.
The move marks one of the most significant global regulatory steps ever undertaken by an Indian developed surgical robotic platform, positioning India prominently in a sector long dominated by international players.
Dr. Sudhir Srivastava, Founder, Chairman, and CEO of SS Innovations, says,“Submitting our 510(k) notification to the FDA is a defining moment, not only for SS Innovations, but for India’s emergence as a global leader in advanced medical technologies. The SSiMantra is designed to be affordable, accessible, and technologically differentiated, and its proven performance across diverse geographies speaks for itself. We believe all hospitals, particularly those serving underserved communities, stand to benefit immensely from an option that is both world-class and cost-effective.”
Following a presubmission meeting and detailed consultations with the FDA, the Company opted for the 510(k) pathway over a De Novo request, seeking to leverage the route’s potential speed and efficiency. The FDA’s target review timeline for 510(k) submissions is 90 days, though total review duration may vary.SS Innovations also continues to advance toward its European Union CE Marking, expected in the first half of 2026, further accelerating the global footprint of the Made-in-India platform.
As of November 30, 2025, the SSi Mantra has achieved:
- 138 systems installed across eight countries
- 137 hospitals actively using the platform
- Over 7,300 surgical procedures, including88 telesurgeries
- 390 cardiac surgeries, one of the most technically demanding robotic domains
- The SSiMantra’s adoption and performance underscore the rising global confidence in an indigenous Indian medical robotics ecosystem, an inflection point for India’s med-tech industry.
SS Innovations International, Inc. (Nasdaq: SSII) has developed innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSII Mantra” surgical robotic system and its comprehensive suite of “SSII Mudra” surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations International
