Shoulder Innovations, Inc. manufactures medical devices. It has developed a shoulder replacement system. The company was founded by Stephen B. Gunther and Michael DeVries in 2009 and is headquartered in Grand Rapids, MI.
Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch
Shoulder Innovations received FDA 510(k) clearance for the N-22 Humeral Head, a titanium implant for shoulder arthroplasty patients with metal hypersensitivity, and simultaneously initiated its full commercial launch.
The Humeral Head is the second product on the company's metal-sensitive technology line, complementing the N-22 Glenosphere cleared in January 2026, and addresses a population where roughly 10% to 15% of people test positive for metal hypersensitivity.
CEO Rob Ball said the clearance gives surgeons a metal-sensitive option across both anatomic and reverse shoulder arthroplasty configurations, reinforcing the company's surgeon and operating-center relationships as it expands its U.S. commercial footprint.