Form 8-K

8-K — SHOULDER INNOVATIONS, INC.

Accession: 0001699350-26-000058

Filed: 2026-10-08

Period: 2026-10-08

CIK: 0001699350

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — si-20261008.htm (Primary)

EX-99.1 (ex-991pressrelease10x8x2026.htm)

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8-K

8-K (Primary)

Filename: si-20261008.htm · Sequence: 1

si-20261008

0001699350false00016993502026-10-082026-10-08

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): October 8, 2026

___________________________________________

SHOULDER INNOVATIONS, INC.

(Exact name of registrant as specified in its charter)

Delaware 001-42771 27-0538764

(State or other jurisdiction of

incorporation) (Commission File Number) (IRS Employer

Identification No.)

1535 Steele Avenue SW, Suite B

Grand Rapids, Michigan

49507

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (616) 294-1026

Not Applicable

(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, $0.001 par value per share SI New York Stock Exchange

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 x

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 October 8, 2026, Shoulder Innovations, Inc. (the “Company”) issued a press release announcing the limited user release of InSet® Go, the Company's next-generation glenoid implant, for use in anatomic shoulder arthroplasty procedures following the successful completion of the first surgical case. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits:

99.1

Press Release of the Company, dated October 8, 2026.

104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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

Dated: October 8, 2026 SHOULDER INNOVATIONS, INC.

(Registrant)

/s/ Jeffrey Points

Jeffrey Points

Chief Financial Officer

EX-99.1

Filename: ex-991pressrelease10x8x2026.htm · Sequence: 2

Document

Exhibit 99.1

Shoulder Innovations Initiates Commercial Launch of the InSet® Go

Limited User Release of the Company’s Next-Generation InSet® Glenoid Implant Follows Successful Completion of First Surgical Case

Grand Rapids, MI – October 8, 2026 – Shoulder Innovations, Inc. (“Shoulder Innovations”, or “the company”) (NYSE: SI), a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, today announced it has initiated a limited user release of the InSet® Go, the company’s next-generation glenoid implant, for use in anatomic shoulder arthroplasty procedures. The first surgical case utilizing the InSet® Go was performed by Robert Gillespie, MD, of University Hospitals Cleveland Medical Center, Cleveland, OH.

The InSet® glenoid technology, including both the implant and surgical technique, was invented more than 20 years ago by Stephen Gunther, MD, to solve the debilitating problem of glenoid implant loosening, the leading cause of failure in anatomic shoulder replacement. The design imprints the implant within a circumferential rim of hard, supportive bone, eliminating the rocking horse mechanism that leads to glenoid loosening. The next-generation InSet® Go maintains this original, clinically-proven design principle to preserve bone, simplify technique, and maximize implant stability. It also further streamlines the operating room experience by reducing the surgical steps involved, offering the potential for reduced procedure times.

“The InSet Go is our next-generation step in a paradigm shift to more long-lasting, pain-free successful surgical results for our patients,” said Stephen Gunther, MD.

The next-generation implant incorporates additional elements of intellectual property that protects key technical components of clinical success, namely the complex articular surface of the InSet® glenoid technology, as well as the Inset® PLUS augmented configurations important for correction of bone loss.

“I’ve been a user of the InSet technology for more than a decade and have achieved remarkable outcomes consistent with published clinical results,” said Chris Chuinard, MD, MPH, of Great Lakes Orthopaedic Center, Traverse City, MI. “The revolution continues with the InSet Go by combining unparalleled lifetime stability with immediate fixation.”

“InSet Go builds on a decade-long track record our surgeons and patients already trust, now paired with a procedure that’s meaningfully more efficient for the surgical team and care facility,” said Rob Ball, CEO of Shoulder Innovations. “We’re encouraged by the robust commercial response we’ve seen so far and look forward to InSet Go’s full commercial introduction over the coming quarters.”

About Shoulder Innovations

Shoulder Innovations is a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, with a current offering of advanced implant systems for shoulder arthroplasty. These systems are a core element of Shoulder Innovations’ ecosystem, which is designed to improve core components of shoulder surgical care – preoperative planning, implant design and procedural efficiency – to benefit each stakeholder in

the care chain. Shoulder Innovations’ ecosystem is also comprised of enabling technologies, efficient instrument systems, specialized support and surgeon-to-surgeon collaboration. Together, these elements seek to address the long-standing clinical and operational challenges in the shoulder surgical care market by delivering predictable outcomes, procedural simplicity, and efficiency across all sites of care.

Contact

Brian Johnston or Sam Bentzinger

Gilmartin Group LLC

ir@shoulderinnovations.com

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