Shoulder Innovations Launches InSet I-135RFX Humeral Stem

Shoulder Innovations has commercially launched its InSet I-135RFX humeral stem following a successful limited market release and receipt of additional U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded set of fracture indications.

The InSet I-135RFX can now be used in all primary, revision, and fracture total shoulder arthroplasty procedures. It joins the smaller form factor InSet 95 and InSet 70, launched in 2024 and 2025, respectively.

The new humeral stem is built on the company’s InSet lateral-lateral implant philosophy, was has been demonstrated in independent, peer-reviewed research to reduce complications and maximize post-op range of motion.

To date, surgeons have used the InSet I-135RFX in both anatomic and reverse shoulder replacement configurations. The company said they value its ease of use, straightforward surgical technique, and integration with Shoulder Innovations’ two-tray surgical instrumentation system.

“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.”

In December, the company formed a strategic partnership with Interventional Systems (INS) to introduce a shoulder-specific micro-robotic solution that will enhance surgical precision, workflow efficiency, and introduce new clinical approaches in the total shoulder arthroplasty and reverse shoulder arthroplasty markets.