Shoulder Innovations launches InSet I-135RFX stem

Shoulder Innovations, Inc. announced the full commercial launch of its InSet™ I-135RFX Humeral Stem, expanding its I-Series shoulder implant portfolio.

Rhea-AI Filing Summary

Shoulder Innovations, Inc. announced the full commercial launch of its InSet™ I-135RFX Humeral Stem, expanding its I-Series shoulder implant portfolio. This launch follows a successful limited market release and FDA 510(k) clearance for additional fracture indications.

The InSet™ I-135RFX can now be used in primary, revision, and fracture total shoulder arthroplasty procedures, in both anatomic and reverse configurations. It joins the InSet™ 95 and InSet™ 70, launched in 2024 and 2025, and is built on the company’s lateral-lateral implant philosophy aimed at reducing complications and improving post-operative range of motion.

Insights

Medical device industry analyst

Shoulder Innovations expands its shoulder implant portfolio with a broader-indication humeral stem.

Shoulder Innovations has moved the InSet™ I-135RFX Humeral Stem from limited release to full commercial launch after obtaining FDA 510(k) clearance for additional fracture indications. The device can now be used across primary, revision, and fracture total shoulder arthroplasty procedures.

This product becomes the third component of the InSet humeral stem system, alongside InSet™ 95 and InSet™ 70, launched in 2024 and 2025. The design leverages the company’s lateral-lateral implant philosophy, which peer-reviewed research has associated with fewer complications and improved range of motion, potentially strengthening the company’s position in complex shoulder cases.

Surgeon feedback in early use highlights ease of use, straightforward technique, and integration with a two-tray instrumentation system. Future disclosures in company communications may provide more detail on adoption trends and the contribution of this expanded indication set to procedure mix and revenue.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Terms

full commercial launch, FDA 510(k) clearance, total shoulder arthroplasty, reverse shoulder arthroplasty, +1 more

5 terms

full commercial launch financial

"today announced full commercial launch of the InSet™ I-135RFX Humeral Stem"

FDA 510(k) clearance regulatory

"receipt of additional FDA 510(k) clearance for an expanded set of fracture indications"

FDA 510(k) clearance is an official approval from the U.S. Food and Drug Administration that allows medical devices to be legally sold in the United States. It indicates the device is considered safe and effective based on its similarity to already approved products. For investors, achieving 510(k) clearance can signal a company's readiness to bring a medical device to market and generate revenue.

total shoulder arthroplasty medical

"utilized in all primary, revision, and fracture total shoulder arthroplasty procedures"

reverse shoulder arthroplasty medical

"utilized the InSet™ I-135RFX in both anatomic and reverse shoulder arthroplasty configurations"

lateral-lateral implant philosophy medical

"built on Shoulder Innovations’ exclusive InSet lateral-lateral implant philosophy"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Shoulder Innovations (SI) announce in this 8-K filing?

Shoulder Innovations announced the full commercial launch of its InSet™ I-135RFX Humeral Stem. This follows a limited market release and additional FDA 510(k) clearance, allowing broader use in primary, revision, and fracture total shoulder arthroplasty procedures across varied clinical scenarios.

What is the InSet™ I-135RFX Humeral Stem from Shoulder Innovations (SI)?

The InSet™ I-135RFX Humeral Stem is a shoulder implant in Shoulder Innovations’ I-Series product line. It is designed for total shoulder arthroplasty, including primary, revision, and fracture procedures, and supports both anatomic and reverse configurations within the company’s InSet humeral stem system.

How does the InSet™ I-135RFX fit into Shoulder Innovations’ (SI) product portfolio?

The InSet™ I-135RFX is the third addition to the I-Series humeral stem line, joining the smaller InSet™ 95 and InSet™ 70 launched in 2024 and 2025. Together, they broaden the company’s advanced implant systems offering for shoulder arthroplasty across a range of patient and procedure types.

What clinical benefits does Shoulder Innovations (SI) highlight for the InSet™ I-135RFX?

Shoulder Innovations notes that the InSet™ I-135RFX uses its exclusive InSet lateral-lateral implant philosophy, which independent peer-reviewed research has shown can reduce complications and maximize post-operative range of motion. Surgeons also value its ease of use, straightforward technique, and integration with a two-tray instrument system.

What regulatory milestone supports the launch of the InSet™ I-135RFX by SI?

The full commercial launch is supported by additional FDA 510(k) clearance for an expanded set of fracture indications. This clearance allows the InSet™ I-135RFX to be used in all primary, revision, and fracture total shoulder arthroplasty procedures, broadening its approved clinical applications in the United States.

How does the InSet™ I-135RFX relate to Shoulder Innovations’ broader ecosystem?

Shoulder Innovations describes its ecosystem as combining implant systems, enabling technologies, efficient instruments, and specialized support. The InSet™ I-135RFX adds to this by addressing complex shoulder arthroplasty needs while aiming for predictable outcomes, procedural simplicity, and efficiency across multiple sites of care.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 04/27/2026 - 07:05 AM EDT Learn about SEC filing dates

0001699350false00016993502026-04-272026-04-27

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): April 27, 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 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.

Item 9.01. Financial Statements and Exhibits.

			(d)			Exhibits:
						99.1			Press Release of the Company, dated April 27, 2026.
						104			Cover Page Interactive Data File (embedded within the Inline XBRL document).

2

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: April 27, 2026			SHOULDER INNOVATIONS, INC. (Registrant)
			/s/ Jeffrey Points
			Jeffrey Points
			Chief Financial Officer

3

Exhibit 99.1

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

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 9.1 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 1.8 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 22.3 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 12.8 KB