SS Innovations files 510(k) submission for SSi Mantra surgical robot

SS Innovations International Inc. said it has filed a 510(k) premarket notification with the U.S. Food and Drug Administration for its SSi Mantra surgical robotic system, a step the company called a major milestone in its plan to expand into the American market.

The Dec. 5 submission seeks clearance for use of the system across a range of specialty procedures, including general, urological, colorectal, gynecological and cardiac surgery, the company said.

Sudhir Srivastava, chairman and CEO of SS Innovations, said the filing represents a significant move toward offering a more affordable surgical robotics option in the United States.

“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,” Srivastava said. “Given its affordability, differentiated technology, and proven performance across our existing global installations, we believe the SSi Mantra represents a highly compelling option for hospitals and surgeons in the United States, especially those serving underserved patient communities.”

The company opted for a 510(k) pathway after a pre-submission meeting and further discussions with the FDA. The approach, it said, may provide faster review timelines and lower costs than a De Novo request.

The FDA aims to complete reviews of 510(k) submissions within 90 days, though the company noted that timing may vary due to additional information requests, a 15-day acceptance review and the submitter’s response time.

SS Innovations is also pursuing European Union CE marking for the SSi Mantra and expects to potentially secure certification in the first half of 2026.

As of Nov. 30, the SSi Mantra’s installed base included 138 systems in eight countries where it is already approved. A total of 137 hospitals have installed the platform, with more than 7,300 procedures completed to date, including 88 telesurgeries and 390 cardiac surgeries.

Advances in surgical robotics highlight expanding possibilities

The surgical robotics sector continues to undergo rapid transformation driven by advances in imaging, automation, connectivity and workflow integration. Innovators are working to reduce system footprint, broaden procedural applications and lower per-procedure costs—trends that are reshaping expectations for the next generation of platforms.

One major area of progress has been system miniaturization. Newer robotic architectures rely on streamlined arms, modular configurations and improved cable management to allow easier setup and better access in crowded operating rooms. These changes are especially significant for community hospitals and ambulatory centers that have limited space but are seeking to adopt robotic capabilities.

Another key development is the integration of advanced visualization and imaging. High-definition 3D optics, fluorescence guidance and real-time anatomical mapping are becoming standard features, enabling surgeons to perform complex tasks with greater clarity. Machine learning tools are also being incorporated to enhance instrument tracking, reduce tremor and suggest optimal motion pathways. While these capabilities are still emerging, they reflect the broader movement toward semi-autonomous assistance.

Connectivity advances are extending surgical reach as well. Improvements in low-latency communication networks are enabling more reliable remote proctoring and early forms of telesurgery. These capabilities could expand access to subspecialty expertise, particularly in underserved regions.

Finally, the industry is placing growing emphasis on cost efficiency. Developers are designing systems with reusable instruments, simplified maintenance and lower capital expenditure requirements. Combined with expanding procedural versatility, these approaches aim to make robotic surgery more economically viable for a wider range of facilities. Collectively, these advances point toward a future in which robotic platforms are more accessible, adaptable and capable across nearly every surgical specialty.