Shoulder Innovations wins FDA clearance for titanium shoulder implant

Shoulder Innovations, Inc. (NYSE: SI) received U.S. Food and Drug Administration 510(k) clearance for its N-22 Humeral Head, a titanium implant designed for patients with metal hypersensitivity, and simultaneously launched the product commercially, according to a press release dated Sept. 10, 2026.

The N-22 Humeral Head is intended for use in anatomic total shoulder arthroplasty procedures. The company states that approximately 10% to 15% of the general population tests positive for metal hypersensitivity, which can result in persistent pain or other allergic symptoms associated with metal implants.

The clearance follows the company's N-22 Glenosphere implant, which received FDA clearance in January 2026 for use in reverse total shoulder arthroplasty procedures involving the same patient population. Together, the two products cover both shoulder arthroplasty configurations for metal-sensitive patients.

"The N-22 Humeral Head augments our line of technologies for patients with metal hypersensitivity, now providing surgeons with a metal-sensitive option across both shoulder arthroplasty configurations," said Rob Ball, CEO of Shoulder Innovations.

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