SS Innovations International has completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital (Baltimore, USA) in September 2025 and anticipates submitting a 510(k) premarket notification to the US Food and Drug Administration for multiple specialty indications in the fourth quarter of 2025.
The completion of the human factors validation study, which is designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for usability and patient safety, marks a key milestone and will form an important part of the company’s forthcoming 510(k) submission.
If the FDA determines that the SSi Mantra can be marketed in the USA, the company believes that such clearance could occur in the first half of 2026 based on standard review timelines, excluding time required by the Company to respond to any additional information requests.
Sudhir Srivastava, chairman of the board and chief executive officer of SS Innovations, commented: “Based on discussions with the FDA and our consultants, we pivoted from filing a de novo request for our SSi Mantra surgical robotic system to pursuing the 510(k) regulatory pathway, which offers potential speed and cost advantages. We have since made excellent progress as highlighted by the recent completion of a human factors validation study conducted at Johns Hopkins Hospital. This study will be an integral part of our 510(k) premarket notification, which we anticipate submitting to the FDA in the fourth quarter of 2025, bringing us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the US market.”
To date, 119 hospitals have installed the SSi Mantra and over 6,000 surgical procedures have been performed, including 60 telesurgeries and 310 cardiac procedures.
