FORT LAUDERDALE, Fla. — December 8, 2025 — Leads & Copy — SS Innovations International, Inc. (SSII) has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its SSi Mantra surgical robotic system, the company announced December 8, 2025.
The submission, made December 5, 2025, covers multiple specialty procedure types, including general, urological, colorectal, gynecological, and cardiac surgery.
SS Innovations International, Inc. (Nasdaq: SSII) develops surgical robotic technologies with a goal of making robotic surgery more affordable and accessible.
SSII Chairman of the Board and Chief Executive Officer, Dr. Sudhir Srivastava, said the submission marks an important milestone in the company’s strategic plan to introduce the cost-efficient SSi Mantra surgical robotic system to the U.S. market. He added that, because of its affordability, differentiated technology, and performance, the SSi Mantra is a compelling option for hospitals and surgeons in the United States, especially those serving underserved patient communities.
Based on discussions with the FDA, the company decided to pursue a 510(k) submission, rather than a De Novo request, for the SSi Mantra surgical robotic system, with the goal of benefiting from the pathway’s potential speed and cost efficiencies.
The FDA has a goal of completing reviews of 510(k) submissions within 90 days of receipt, but the release cautioned that the time to approval could be longer due to factors such as the 15-day acceptance review, the submission of additional information, and submitter response time.
The company is also pursuing a European Union CE marking certification for the SSi Mantra, which it believes it could obtain in the first half of 2026.
As of November 30, 2025, the SSi Mantra had a cumulative installed base of 138 systems across eight countries with regulatory approval. To date, the SSi Mantra has been installed in 137 hospitals, and more than 7,300 surgical procedures have been performed, including 88 telesurgeries and 390 cardiac procedures.
The SSi Mantra surgical robotic system is a modular, multi-arm system that includes three to five modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for patient information, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. It utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and has been clinically validated in India in more than 100 surgical procedures.
The vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon.
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Source: SS Innovations International, Inc.
