SS Innovations Submits 510(k) Premarket Notification to the FDA for the Company’s SSi Mantra Surgical Robotic System

Core Viewpoint - SS Innovations International, Inc. has submitted a 510(k) premarket notification to the FDA for its SSi Mantra surgical robotic system, aiming to enhance accessibility and affordability of robotic surgery in the U.S. market [1][2] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies to make robotic surgery accessible to a broader global population [5] - The company is headquartered in India and aims to expand its global presence with cost-effective surgical robotic solutions [5] Product Details - The SSi Mantra surgical robotic system features a modular design with 3 to 5 robotic arms, an ergonomic command center, and advanced imaging capabilities [6] - It has been clinically validated in India for over 100 different types of surgical procedures [6] Regulatory Progress - The FDA aims to complete reviews of 510(k) submissions within 90 days, although actual approval times may vary [3] - The company is also pursuing CE marking certification in the European Union, expected in the first half of 2026 [3] Market Presence - As of November 30, 2025, the SSi Mantra has a cumulative installed base of 138 systems across eight countries, with 137 hospitals utilizing the system [4] - Over 7,300 surgical procedures have been performed using the SSi Mantra, including 88 telesurgeries and 390 cardiac procedures [4]