SS Innovations Submits 510(k) for SSi Mantra Surgical Robot to FDA

SS Innovations has filed a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) for its SSi Mantra surgical robotic system, aiming to enter the world’s largest robotic surgery market. The company seeks clearance for multiple indications, including general, urological, colorectal, gynecological, and cardiac surgery, offering a lower-cost, multi-specialty alternative to robotics leader Intuitive Surgical.

The SSi Mantra is already installed in 138 systems across eight countries, with over 7,300 procedures completed, including 88 telesurgeries and 390 cardiac cases. In India, it has been clinically validated across more than 100 procedure types. Priced at less than one-third of an Intuitive system, the robot aims to broaden access to minimally invasive surgery.

SS Innovations chose the 510(k) pathway to potentially shorten review time and reduce costs, with the FDA’s target being 90 days. The company is also pursuing a CE mark in the EU, expected in H1 2026, and is developing telesurgery capabilities.

18-12-2025