Shoulder Innovations Launches InSet™ I-135RFX Humeral Stem Following FDA Clearance

Grand Rapids, MI – April 27, 2026: Shoulder Innovations, Inc. (NYSE: SI), a commercial-stage medical technology company focused exclusively on the shoulder surgical care market, has announced the full commercial launch of its InSet™ I-135RFX Humeral Stem. This follows a successful limited market release and the receipt of expanded FDA 510(k) clearance for additional fracture indications, allowing the device to be used in all primary, revision, and fracture total shoulder arthroplasty procedures.

Key Points for Investors

• Full Commercial Launch: The InSet™ I-135RFX Humeral Stem is now fully available in the U.S. market after a phased release and additional regulatory approval.
• Expanded FDA Indications: The device can now be utilized for a wider range of clinical scenarios, including all primary, revision, and fracture total shoulder arthroplasty procedures. This significantly expands the total addressable market for Shoulder Innovations.
• Third Addition to Product Line: The InSet™ I-135RFX is the third product in the I-Series humeral stem line, joining the InSet™ 95 (launched in 2024) and InSet™ 70 (launched in 2025). This steady cadence of product launches demonstrates the company’s innovative capabilities and commitment to market leadership.
• Clinical Validation: The InSet lateral-lateral implant philosophy, upon which the new product is based, has shown in peer-reviewed research to reduce complications and maximize range of motion for post-operative patients.
• Surgeon Adoption and Feedback: To date, surgeons have successfully used the InSet™ I-135RFX in both anatomic and reverse shoulder arthroplasty procedures, citing its ease of use, straightforward surgical technique, and seamless integration with the company’s two-tray surgical instrumentation system.

Potentially Price Sensitive Information

• Market Expansion: The FDA clearance for expanded indications is a significant development, enabling Shoulder Innovations to target a broader patient population and potentially drive increased sales and market share.
• Product Portfolio Strength: The rapid expansion and diversification of the I-Series product line positions the company as a leading innovator in the shoulder arthroplasty market, which may attract further investor interest and enhance competitive positioning.
• Milestone Achievement: According to CEO Rob Ball, this launch marks an important milestone, demonstrating the company’s ability to address the full spectrum of shoulder arthroplasty procedures and deliver meaningful improvements in patient outcomes, even in the most challenging clinical scenarios.

Company Overview and Strategic Vision

Shoulder Innovations is a commercial-stage medical technology company committed to transforming the shoulder surgical care market. Its ecosystem includes advanced implant systems, efficient instrument systems, enabling technologies, specialized support, and surgeon-to-surgeon collaboration. The company’s integrated approach aims to improve preoperative planning, implant design, and procedural efficiency—addressing longstanding clinical and operational challenges and delivering predictable outcomes, procedural simplicity, and efficiency across all sites of care.

Contact Information

• Investor Relations: Brian Johnston or Sam Bentzinger, Gilmartin Group LLC
  [email protected]

Disclaimer: This article is for informational purposes only and is not intended as investment advice. Investors should conduct their own due diligence or consult a qualified financial advisor before making investment decisions related to Shoulder Innovations, Inc. or any other securities.

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