In context
In late 2025, the surgical robotics market was increasingly competitive, with established players facing pressure from more affordable, multi-specialty platforms. SS Innovations, a developer of surgical robotic technologies, sought to expand its global footprint by entering the US market, a key strategic move given the high demand for cost-effective robotic surgery solutions.
What was reported
SS Innovations submitted a 510(k) premarket notification to the US FDA for its SSi Mantra surgical robotic system, covering multiple specialties: general, urological, colorectal, gynecological, and cardiac surgery. The company chose the 510(k) pathway over a De Novo request, following pre-submission discussions with the FDA, to benefit from potential speed and cost efficiencies.
The FDA aims to review 510(k) submissions within 90 days, though approval may take longer due to acceptance review and additional information requests. Separately, the company continues pursuing CE marking in the EU, with expected approval 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 137 hospitals using the system. Over 7,300 surgical procedures had been performed, including 88 telesurgeries and 390 cardiac procedures.
Why it mattered
The FDA submission marked a significant step toward introducing an affordable, multi-specialty surgical robot to the US market, potentially increasing access to robotic surgery for underserved communities and intensifying competition among established players.
“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.”
Source: Robotics & Automation News (roboticsandautomationnews.com) · Published 2025-12-09 · “SS Innovations applies for FDA approval for its Mantra robotic surgical system”