Shoulder Innovations Launches N-22 Humeral Head After FDA Clearance
Shoulder Innovations, Inc. (NYSE: SI) has received FDA 510(k) clearance for its N-22 Humeral Head implant and launched it commercially in the U.S. The product is designed to address metal hypersensitivity issues among patients undergoing anatomic total shoulder arthroplasty procedures. The company's new titanium-based humeral head complements its previously cleared N-22 Glenosphere, which was approved for reverse total shoulder arthroplasty in January 2026. Together, these implants provide a comprehensive solution for metal-sensitive patients who may experience allergic reactions to traditional metallic components used in joint replacements. CEO Rob Ball emphasized the importance of this product addition as it enhances surgeon options and strengthens relationships with operating centers across the U.S., supporting Shoulder Innovations' broader mission to transform shoulder surgical care through advanced implant systems.
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