Shoulder Innovations, a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the N-22 Humeral Head, a titanium implant option for patients with metal hypersensitivity. Alongside the clearance, the company also announced the product's full commercial launch.

Approximately 10 per cent to 15 per cent of the general population test positive for metal hypersensitivity and may experience persistent pain or other symptoms associated with allergic reactions from metal implants. The N-22 Humeral Head is designed for use in anatomic total shoulder arthroplasty procedures involving patients with these complications and complements the company's N-22 Glenosphere implant, cleared in January 2026, which is used in reverse total shoulder arthroplasty procedures involving the same patient population.

"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. "As we continue to expand our commercial footprint across the U.S., even small incremental additions to our product line can have a meaningful impact on our relationships with surgeons and operating centers."