SS Innovations said Monday it filed a 510(k) premarket notification with the Food and Drug Administration for its SSi Mantra surgical robotic system.
In the submission, SS Innovations is seeking clearance for indications including general, urological, colorectal, gynecological and cardiac surgery, as it looks to bring a lower-cost, multi-specialty platform to the U.S. market that can compete with robotics leader Intuitive Surgical.
The company is one of a growing roster of robot developers working to bring new surgical systems to the U.S. market, the world’s largest for robotic-assisted procedures. While many smaller organizations are in the clinical trial phase, medtech heavyweight Medtronic reached a milestone last week with the FDA’s clearance of the Hugo soft tissue system in urologic procedures.
SS Innovations said it chose to pursue the 510(k) pathway, rather than the de novo request it initially considered, to potentially speed the review process and lower costs. The FDA targets a 90-day timeline for 510(k) reviews, though the process can take longer.
The SSi Mantra currently has an installed base of 138 systems across eight countries, with more than 7,300 surgical procedures completed to date, including 88 telesurgeries and 390 cardiac cases, according to the company. In India, the system has been clinically validated in more than 100 different types of procedures, the company said.
In a recent interview with MedTech Dive, SS Innovations CEO and founder Sudhir Srivastava said the cost of an SSi Mantra robot in India is less than one-third the price of an Intuitive system. With the SSi Mantra, the company hopes to expand access to robotic surgery to more patients who can benefit from the less-invasive technology. In addition to increasing its geographic reach, SS Innovations is developing telesurgery capabilities and sees cardiac procedures as an important market for its robot.
“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,” Srivastava said in announcing the company’s FDA filing.
SS Innovations is also pursuing a CE mark in the European Union, which it expects to obtain in the first half of 2026.
