SS Innovations (NASDAQ: SSII) plans 510(k) filing for SSi Mantra robot

Rhea-AI Filing Summary

SS Innovations International, Inc. reported that it has successfully completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025. The company also stated that it anticipates submitting a 510(k) premarket notification to the U.S. Food and Drug Administration for SSi Mantra for multiple specialty indications in the fourth quarter of 2025. These steps mark progress in the company’s effort to bring its surgical robotic system to the U.S. market, although regulatory clearance has not yet been obtained.

Insights

Medical device regulatory analyst

SS Innovations advances SSi Mantra toward an FDA 510(k) submission, but no clearance yet.

SS Innovations reports successful completion of a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025. Human factors validation focuses on how clinicians interact with the device, which is an important component of the overall safety and usability package for U.S. regulatory review.

The company also indicates it anticipates submitting a 510(k) premarket notification to the FDA in the fourth quarter of 2025 for multiple specialty indications. A 510(k) submission is a key step in seeking U.S. market clearance but does not guarantee approval or define timing beyond the company’s stated expectation.

From an investment perspective, this update signals that development work on SSi Mantra is progressing into a more formal regulatory phase. Actual commercial and financial impact will depend on the content and outcome of the 510(k) review and any subsequent adoption, which are not addressed in this disclosure.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 2, 2025

SS INNOVATIONS INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

Florida		001-42615		47-3478854
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

405, 3rd Floor, iLabs Info Technology Centre Udyog Vihar, Phase III Gurugram, Haryana India		122016
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: +91 73375 53469

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each Class		Trading Symbol		Name of each exchange on which registered
Common Stock		SSII		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

As used in this Current Report on Form 8-K (this “Current Report”), the terms “SSi,” “the Company,” “we,” “us” and “our” refer to SS Innovations International, Inc. and its subsidiaries.

Item 8.01 Other Events.

On October 2, 2025, the Company issued a press release announcing that the Company successfully completed a human factors validation study for its SSi Mantra surgical robotic system (the “SSi Mantra”) at Johns Hopkins Hospital in September 2025 and anticipates submitting a 510(k) premarket notification to the United States Food and Drug Administration for the SSi Mantra for multiple specialty indications in the fourth quarter of 2025.

A copy of the press release is included as Exhibit 99.1 to this Current Report.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release, dated October 2, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: October 3, 2025	SS INNOVATIONS INTERNATIONAL, INC.
	By:	/s/ Sudhir Srivastava
		Sudhir Srivastava, M.D.
		Chairman and Chief Executive Officer

2

FAQ

What did SS Innovations (SSII) announce in this 8-K filing?

SS Innovations announced that it successfully completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025 and that it anticipates submitting a 510(k) premarket notification to the U.S. Food and Drug Administration in the fourth quarter of 2025.

What is the SSi Mantra system mentioned by SSII?

The SSi Mantra is SS Innovations’ surgical robotic system. In this filing, the company reports progress on a human factors validation study and plans for a 510(k) submission for multiple specialty indications, but it does not provide technical or commercial details about the system.

Has SS Innovations received FDA clearance for SSi Mantra yet?

No. The company states that it has completed a human factors validation study and anticipates submitting a 510(k) premarket notification for SSi Mantra in the fourth quarter of 2025. The filing does not state that any FDA clearance has been granted.

What is the significance of the human factors validation study for SSII?

The human factors validation study evaluates how users interact with the SSi Mantra system, focusing on safety and usability. Completing this study at Johns Hopkins Hospital is an important preparatory step for a 510(k) submission to the FDA but is not itself a marketing authorization.

What future regulatory step does SS Innovations plan for SSi Mantra?

SS Innovations states that it anticipates submitting a 510(k) premarket notification to the U.S. Food and Drug Administration in the fourth quarter of 2025 for SSi Mantra for multiple specialty indications.

Does this SSII 8-K filing include any financial results or transactions?

No. This 8-K focuses on an Other Events disclosure about clinical and regulatory progress for the SSi Mantra system and references a related press release. It does not provide financial results or describe major financial transactions.