[8-K] SiNtx Technologies, Inc. Reports Material Event

Rhea-AI Filing Summary

On 22 Jul 2025, SINTX Technologies (SINT) filed a Form 8-K (Item 7.01) to furnish a press release announcing it has submitted a 510(k) application to the U.S. Food & Drug Administration for silicon-nitride foot & ankle medical devices. The disclosure is informational only and is not deemed “filed” for liability purposes. No financial statements, revenue guidance, or cost estimates accompany the submission. While the filing marks a key regulatory milestone that could enable U.S. commercialization, the company did not provide an expected review timeline, market size, or projected financial impact.

Insights

Medical Device Analyst

TL;DR: 510(k) filing is a necessary step but financial impact hinges on FDA clearance.

The submission signals progress in SINTX’s plan to commercialize silicon-nitride implants in orthopedics. 510(k) reviews typically run 90–180 days, yet outcomes can vary, and supplement questions can extend the process. Without approval, no revenue is generated, so investors should treat this as an option value rather than a guaranteed catalyst. The lack of disclosed market sizing or reimbursement strategy limits valuation clarity. Overall impact: modestly positive but speculative.

Risk Analyst

TL;DR: Milestone achieved, but regulatory and execution risks remain high.

The filing contains no material financial commitments, so downside is limited to R&D spend already incurred. However, failure to secure clearance would impair growth narratives and could pressure future capital raises. Investors should monitor: (1) FDA follow-up queries, (2) timing versus cash runway, and (3) competitive landscape in foot & ankle implants. Absence of quantitative data reduces immediate valuation impact.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

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

Date of Report (Date of earliest event reported): July 22, 2025

SINTX Technologies, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-33624		84-1375299
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

1885 West 2100 South

Salt Lake City, UT 84119

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (801) 839-3500

(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:

☐	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(s):		Name of each exchange on which registered:
Common Stock, par value $0.01 per share		SINT		The NASDAQ Capital Market

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. ☐

Item 7.01. Regulation FD. Disclosure.

On July 22, 2025, SINTX Technologies, Inc. (the “Company”) issued a press release announcing the submission to the U.S. Food and Drug Administration of an FDA 510(k) for Silicon Nitride Foot & Ankle Medical Devices. The full text of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore, the information contained in this Item 7.01 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.		Description
99.1		Press Release, dated July 22, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

			SINTX Technologies, Inc.
Date:	July 22, 2025		By:	/s/ Eric K. Olson
				Eric K. Olson
				Chief Executive Officer

FAQ

What did SINTX (SINT) announce in the July 22 2025 8-K?

The company disclosed it has submitted a 510(k) application to the FDA for silicon-nitride foot & ankle devices.

Does the 8-K include any financial results or guidance for SINTX?

No. The filing is limited to the regulatory submission and contains no revenue, earnings, or cash flow data.

When might the FDA decide on SINTX’s 510(k) submission?

Typical 510(k) reviews take 90–180 days, but the company did not give a specific timeline.

Is the information in Item 7.01 considered "filed" under the Exchange Act?

No. It is being furnished, not filed, so it is not subject to Section 18 liability.

What is the potential impact on SINTX stock?

Positive if clearance is obtained, but financial impact remains uncertain until approval and market launch.