Shoulder Innovations

Shoulder Innovations Wins FDA 510(k) Clearance for N-22 Humeral Head, Launches Titanium Implant for Metal-Sensitive Patients

- Shoulder Innovations received FDA 510(k) clearance for its N-22 Humeral Head, a titanium implant option designed for patients with metal hypersensitivity. - The company simultaneously initiated full commercial launch of the device, its second product on a new line of technologies for metal-sensitive patients. - The N-22 Humeral Head is intended for anatomic total shoulder arthroplasty and complements the N-22 Glenosphere, cleared in January 2026 for reverse procedures. - Roughly 10% to 15% of the general population test positive for metal hypersensitivity and may experience persistent pain from metal implants.