Shoulder Innovations Launches InSet I-135RFX Stem with FDA Fracture Clearance
Shoulder Innovations launched the InSet I-135RFX Humeral Stem commercially after securing FDA 510(k) clearance for expanded fracture indications, enabling its use in primary, revision and fracture shoulder arthroplasty procedures. This third I-Series product, following the InSet 95 and 70, broadens the company’s implant portfolio and sales potential.
1. FDA Clearance and Full Launch
The InSet I-135RFX received FDA 510(k) clearance for additional fracture indications, allowing use in all primary, revision and fracture shoulder arthroplasty procedures. Following a successful limited market release, Shoulder Innovations has commenced full commercial distribution of the humeral stem across its U.S. sales network.
2. I-Series Product Line Growth
This launch marks the third addition to the I-Series humeral stem lineup, joining the InSet 95 (launched 2024) and InSet 70 (launched 2025). Each product leverages the company’s lateral-lateral implant design philosophy, underscoring a steady innovation pipeline and commitment to expanding surgical options.
3. Clinical and Market Benefits
Surgeons report the I-135RFX stem offers ease of use, straightforward surgical technique and seamless integration with a two-tray instrumentation system. The expanded indication set and product familiarity are expected to drive higher procedure volume and strengthen Shoulder Innovations’ position in the shoulder arthroplasty market.