Shoulder Innovations Inc. (NYSE: SI) announced the full commercial launch of its InSet I-135RFX Humeral Stem on April 27, 2026. The launch follows a limited market release and additional FDA 510(k) clearance for expanded fracture indications.

The InSet I-135RFX can now be used in primary, revision, and fracture total shoulder arthroplasty procedures. The device represents the third addition to the company's I-Series humeral stem product line, following the InSet 95 launched in 2024 and InSet 70 launched in 2025.

"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.

The InSet I-135RFX is built on the company's lateral-lateral implant philosophy, which the company states has been shown in peer-reviewed research to reduce complications and maximize post-operative range of motion. Surgeons have used the device in both anatomic and reverse shoulder arthroplasty configurations.

Shoulder Innovations is a commercial-stage medical technology company focused on shoulder surgical care, offering implant systems for shoulder arthroplasty procedures. The company's ecosystem includes preoperative planning tools, implant design, and procedural efficiency components.