SS Innovations International announced Thursday a strategic regulatory pivot for its SSi Mantra surgical robotic system, switching from a de novo request to the 510(k) pathway for FDA approval. The India-based company expects to submit its premarket notification in the fourth quarter of 2025 and anticipates potential clearance in the first half of 2026.
The decision to pursue the 510(k) route instead of the originally planned de novo request was made to potentially reduce both time and costs associated with the regulatory process. Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, explained that the pivot was based on discussions with the FDA and consultants, highlighting the "potential speed and cost advantages" of the 510(k) pathway.
Clinical Validation Milestone
A critical regulatory milestone was achieved in September 2025 when SS Innovations completed a human factors validation study at Johns Hopkins Hospital. This study was designed to provide essential evidence that the SSi Mantra meets FDA requirements for usability and patient safety, and will form an integral part of the upcoming 510(k) submission.
The company has engaged RQM+, a leading MedTech-focused contract research organization, to assist with the 510(k) submission process. SS Innovations plans to apply for multiple surgical specialty indications for the SSi Mantra system in the U.S. market.
Market Performance and Technical Capabilities
The SSi Mantra has demonstrated significant clinical adoption in approved markets. As of September 30, 2025, the system's cumulative installed base totaled 125 units across six countries where regulatory approval has been obtained. A total of 119 hospitals have installed the system, with over 6,000 surgical procedures performed to date, including 60 telesurgeries and 310 cardiac procedures.
The SSi Mantra is described as a user-friendly, modular, multi-arm system featuring 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, and a large 3D 4K monitor. The system includes advanced technology features such as a touch panel monitor for patient information display, virtual real-time imaging of robotic patient-side arm carts, and the ability for superimposition of 3D models from diagnostic imaging.
Competitive Positioning
SS Innovations is positioning itself to challenge Intuitive Surgical in the U.S. soft tissue robotic surgery market. The company emphasizes its mission to make robotic surgery more affordable and accessible to a global population. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support various specialties, including cardiac surgery.
The system has been clinically validated in India across more than 100 different types of surgical procedures. In addition to U.S. regulatory efforts, SS Innovations is also pursuing CE mark approval in Europe.
Regulatory Timeline
Based on standard FDA review timelines, SS Innovations believes clearance could occur in the first half of 2026, though this projection excludes any time that may be required to respond to additional information requests from the agency. The company's regulatory strategy reflects a broader effort to expand the global presence of its surgical robotic solutions while maintaining focus on cost-effectiveness and technological advancement.
