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

Rhea-AI Summary

SS Innovations (Nasdaq: SSII) submitted a 510(k) premarket notification to the FDA on Dec 5, 2025 for the SSi Mantra surgical robotic system covering general, urological, colorectal, gynecological and cardiac surgeries.

The company said it chose the 510(k) pathway following FDA pre-submission talks to seek faster, lower-cost review; the FDA aims for 90-day reviews but noted potential delays from the 15-day acceptance review or requests for more information. SS Innovations also expects possible EU CE marking in H1 2026.

As of Nov 30, 2025, the SSi Mantra installed base totaled 138 systems across eight countries, with 137 hospitals and over 7,300 procedures performed, including 88 telesurgeries and 390 cardiac procedures.

Positive

• Submitted 510(k) to FDA on Dec 5, 2025
• Installed base of 138 systems across eight countries
• 7,300+ surgical procedures performed to date
• Company expects possible EU CE marking in H1 2026

Negative

• FDA 510(k) review may exceed 90 days due to acceptance review and info requests
• 510(k) submission is not an approval; market access depends on FDA decision

Key Figures

FDA review goal 90 days FDA stated goal to complete 510(k) reviews

Acceptance review period 15 days Initial 510(k) acceptance review duration cited by FDA

Installed base 138 systems SSi Mantra cumulative installed base as of Nov 30, 2025

Countries with approvals 8 countries Markets where SSi Mantra has regulatory approval

Hospitals installed 137 hospitals Hospitals that have installed SSi Mantra

Total procedures over 7,300 Surgical procedures performed using SSi Mantra

Telesurgeries 88 telesurgeries Subset of SSi Mantra procedures performed remotely

Cardiac procedures 390 procedures Cardiac surgeries completed with SSi Mantra

Market Reality Check

$5.82 Last Close

Volume Volume 123,608 is 1.81x the 20-day average of 68,178, indicating elevated pre-news activity. high

Technical Shares at $6.21 were trading below the 200-day MA of $7.53 and 72.3% below the 52-week high of $22.42.

Peers on Argus

Peers in Medical Devices showed mixed moves: IART -2.43%, AHCO +1.07%, BBNX -3.51%, ESTA +0.33%, NVCR +2.19%, suggesting the SSII catalyst is stock-specific rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 06	Technology milestone	Positive	-2.3%	Announced first telesurgery using SSi Mantra Tele Surgeon Console.
Oct 28	Quarterly earnings	Positive	-0.9%	Reported strong Q3 2025 revenue and installation growth with ongoing losses.
Oct 21	Investor conferences	Neutral	-0.7%	Planned participation in UBS and Stifel healthcare investor conferences.
Oct 02	Regulatory update	Positive	-8.6%	Completed human factors study and shifted U.S. plan to 510(k) pathway.
Sep 26	Management change	Positive	-1.6%	Appointed experienced new CFO while prior interim CFO remained CEO APAC.

Pattern Detected

Over the last five events, SSII’s shares moved negatively in the 24 hours after each announcement, including positive operational and regulatory updates.

Recent Company History

Over the past few months, SSII reported strong Q3 2025 revenue growth, expanded its SSi Mantra installed base, completed a human factors validation study, and executed its first telesurgery using the Tele Surgeon Console. Management also refreshed leadership with a new CFO and engaged investors via conferences and updated presentations. Despite these milestones, each prior news item was followed by a negative 24-hour price move, providing context for how the market had reacted to earlier strategic and regulatory progress ahead of this 510(k) submission.

Market Pulse Summary

This announcement details SSII’s submission of a 510(k) premarket notification to the FDA for its SSi Mantra surgical robotic system, spanning multiple surgical specialties and supported by an installed base of 138 systems across 8 countries with over 7,300 procedures. It also reiterates progress toward EU CE marking. In context of prior updates about shifting from a De Novo strategy and growing telesurgery experience, investors may watch for FDA review milestones and European certification timing.

Key Terms

510(k) regulatory

"submitted a 510(k) premarket notification to the United States Food and Drug Administration"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

premarket notification regulatory

"submitted a 510(k) premarket notification to the United States Food and Drug Administration"

A premarket notification is a regulatory submission companies send to a health authority (for example, the U.S. Food and Drug Administration) to show a medical device is similar enough to an existing, approved product to be marketed. For investors, clearance from a premarket notification is like getting a green light to sell a product — it reduces regulatory uncertainty, shortens time to revenue, and lowers the risk that a new device will be blocked or delayed.

food and drug administration regulatory

"premarket notification to the United States Food and Drug Administration (the “FDA”)"

A government agency that reviews and regulates medicines, medical devices, food safety, and related products to ensure they are safe and effective for public use. Investors watch its actions like a referee’s calls: approvals, warnings, inspections or recalls can directly affect a product’s ability to reach the market, a company’s sales and costs, and overall business risk and valuation.

ce marking regulatory

"continues along the pathway towards a European Union CE marking certification"

CE marking is a symbol placed on certain products showing they meet European Union safety, health and environmental rules required to sell them in the EU/EEA. For investors, it signals that a product has cleared a common regulatory hurdle—like a passport for market access—reducing legal and market-entry risk and often widening sales opportunities across European markets.

telesurgeries medical

"over 7,300 surgical procedures have been performed, including 88 telesurgeries"

Surgery performed by a clinician who is physically distant from the patient, using robotic instruments, real‑time video and sensors controlled over high‑speed networks; think of a surgeon using a precise game controller to operate tools in another location. Investors care because telesurgeries can expand patient access, shift where care happens, and create new markets for medical robots, software and communications, while also carrying regulatory, reimbursement and liability uncertainties that affect adoption and returns.

cardiac surgery medical

"procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery"

Operations that repair, replace or otherwise treat the heart and its nearby blood vessels, ranging from bypass grafts to valve replacements and implanting devices. For investors, cardiac surgery matters because it drives demand for hospitals, surgical devices, implants, and recovery therapies—similar to how major engine repairs create work for parts makers and mechanics—so changes in procedure rates, technology, regulation, or costs can materially affect medical companies’ revenues and margins.

AI-generated analysis. Not financial advice.

-- Submission covers multiple indications including general, urological, colorectal, gynecological and cardiac surgeries --

FORT LAUDERDALE, Fla., Dec. 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) on December 5, 2025, for the SSi Mantra surgical robotic system for multiple specialty procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery.

Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Our submission of a 510(k) premarket notification to the FDA marks an important milestone in our strategic plan to introduce the Company’s advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.   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.”

Based on a pre-submission meeting and subsequent 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, aiming to benefit from the pathway’s potential speed and cost efficiencies.

The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval could be longer due to factors such as the 15-day acceptance review, the submission of additional information, and a submitter's response time.

Separately, the Company continues along the pathway towards a European Union CE marking certification for the SSi Mantra that it believes it could obtain in the first half of 2026.

As of November 30, 2025, the SSi Mantra cumulative installed base totaled 138 systems across eight countries where the Company’s surgical robotic system has received regulatory approval. To date, 137 hospitals have installed the SSi Mantra and over 7,300 surgical procedures have been performed, including 88 telesurgeries and 390 cardiac procedures. 

About SS Innovations
SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.

About the SSi Mantra
The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures.

Forward Looking Statements
This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

Investor Contact:
The Equity Group        
Kalle Ahl, CFA                
T: (303) 953-9878        
kahl@theequitygroup.com

Devin Sullivan, Managing Director
T: (212) 836-9608
dsullivan@theequitygroup.com

Media Contact:
RooneyPartners LLC
Kate Barrette
T: (212) 223-0561
kbarrette@rooneypartners.com

FAQ

What did SS Innovations (SSII) submit to the FDA on Dec 5, 2025?

SS Innovations submitted a 510(k) premarket notification for the SSi Mantra surgical robotic system covering multiple specialties.

Which surgical procedures are included in the SSi Mantra 510(k) submission for SSII?

The submission covers general, urological, colorectal, gynecological, and cardiac surgeries.

How long does the FDA take to review a 510(k) like SSII’s SSi Mantra submission?

The FDA aims to complete 510(k) reviews within 90 days, but review time can be longer due to the 15-day acceptance review or requests for more information.

How many SSi Mantra systems has SS Innovations (SSII) installed as of Nov 30, 2025?

As of Nov 30, 2025, the installed base totaled 138 systems across eight countries with 137 hospitals.

How many procedures and cardiac cases have SSII’s SSi Mantra systems performed?

The systems have performed over 7,300 procedures, including 390 cardiac procedures and 88 telesurgeries.

When does SS Innovations expect possible CE marking for the SSi Mantra?

The company believes it could obtain EU CE marking in the first half of 2026.