Shoulder Innovations received U.S. Food and Drug Administration (FDA) 510(k) clearance (device marketing authorization) for the N-22 Humeral Head, a titanium implant designed for patients with metal hypersensitivity, and announced its full commercial launch. The product is intended for anatomic total shoulder arthroplasty, complementing the N-22 Glenosphere, which was cleared in January 2026 for reverse total shoulder arthroplasty in the same patient population. The company said approximately 10% to 15% of the general population test positively for metal hypersensitivity and may experience persistent pain or other allergic-reaction symptoms from metal implants.