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

Core Viewpoint - SS Innovations has submitted a 510(k) premarket notification to the FDA for its SSi Mantra surgical robotic system, targeting multiple surgical specialties and aiming for U.S. market entry [1][3][5] Company Overview - SS Innovations International, Inc. is focused on developing innovative surgical robotic technologies to make robotic surgery affordable and accessible globally [8] - The company is headquartered in India and plans to expand its global presence with cost-effective surgical robotic solutions [8] Product Details - The SSi Mantra surgical robotic system supports various surgical specialties, including general, urological, colorectal, gynecological, and cardiac procedures [2][3] - The system features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, a large 3D 4K monitor, and over 40 types of robotic endo-surgical instruments [10] Regulatory Progress - The 510(k) submission is part of the company's strategic plan to introduce the SSi Mantra system to the U.S. market, with the expectation of a review completion within 90 days, although actual approval may take longer [6] - The company is also pursuing EU CE Mark approval, which it anticipates could be obtained in the first half of 2026 [6] 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 and over 7,300 surgical procedures performed [6]