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Shoulder Innovations Initiates Full Commercial Launch of the InSet™ I-135RFX Humeral Stem

SI
  • Shoulder Innovations, Inc. (NYSE: SI) announced the full commercial launch of the InSet™ I-135RFX Humeral Stem on April 27, 2026.
  • The launch follows a successful limited market release & receipt of additional FDA 510(k) clearance for expanded fracture indications.
  • The device is now approved for all primary, revision, & fracture total shoulder arthroplasty procedures.
  • The InSet™ I-135RFX is the third addition to the I-Series humeral stem line, following the InSet™ 95 (2024) & InSet™ 70 (2025).
  • The product utilizes the company's exclusive InSet lateral-lateral implant philosophy, which research shows reduces complications & maximizes post-operative range of motion.
  • Surgeons have utilized the implant in both anatomic & reverse shoulder arthroplasty configurations.
  • The device features ease of use, a straightforward surgical technique, & integration with the company's two-tray surgical instrumentation system.