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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 27, 2026
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| SHOULDER INNOVATIONS, INC. |
| (Exact name of registrant as specified in its charter) |
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| Delaware | | 001-42771 | | 27-0538764 |
(State or other jurisdiction of
incorporation) | | (Commission File Number) | | (IRS Employer
Identification No.) |
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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)
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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:
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| 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. ☐
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| Item 7.01. | Regulation FD Disclosure. |
On April 27, 2026, Shoulder Innovations, Inc. (the “Company”) issued a press release announcing the full commercial launch of the InSet™ I-135RFX Humeral Stem. 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.
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| Item 9.01. | Financial Statements and Exhibits. |
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| (d) | Exhibits: |
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| | 99.1 | Press Release of the Company, dated April 27, 2026. |
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| | 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.
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| Dated: April 27, 2026 | SHOULDER INNOVATIONS, INC.
(Registrant) |
| |
| |
| /s/ Jeffrey Points |
| Jeffrey Points |
| Chief Financial Officer |
Shoulder Innovations Initiates Full Commercial Launch of the InSet™ I-135RFX Humeral Stem
Latest Addition to I-Series Product Line Follows a Successful Limited Market Release and FDA Clearance of Additional Fracture Indications
Grand Rapids, MI – April 27, 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 full commercial launch of the InSet™ I-135RFX Humeral Stem (“InSet™ I-135RFX”).
The commencement of full launch follows a successful limited market release and receipt of additional FDA 510(k) clearance for an expanded set of fracture indications, enabling the InSet™ I-135RFX to now be utilized in all primary, revision, and fracture total shoulder arthroplasty procedures.
“The addition of the InSet I-135RFX to our best-in-class suite of shoulder surgical care solutions is an important milestone for SI, enabling us to now support the full spectrum of shoulder arthroplasty procedures our surgeon customers perform,” said Rob Ball, CEO of Shoulder Innovations. “As the third addition to our InSet Humeral Stem System in as many years, this launch reflects the strength of our innovation engine and our commitment to delivering meaningful improvements in patient outcomes, even in the most challenging of clinical scenarios.”
The InSet™ I-135RFX joins the smaller form factor InSet™ 95 and InSet™ 70, launched in 2024 and 2025, respectively, as the third addition to the I-Series humeral stem product line. Consistent with these earlier products, the InSet™ I-135RFX is built on Shoulder Innovations’ exclusive InSet lateral-lateral implant philosophy, which has been shown in independent, peer reviewed research to reduce complications and maximize post-operative range of motion.
To date, surgeons have utilized the InSet™ I-135RFX in both anatomic and reverse shoulder arthroplasty configurations and specifically value its ease of use, straightforward surgical technique, and seamless integration with Shoulder Innovations' two-tray surgical instrumentation system.
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
