MedTech News

.................... by Andrew Celentano

Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch

GRAND RAPIDS, Mich., Sept. 10, 2026 /PRNewswire/ — Shoulder Innovations, Inc. (“Shoulder Innovations”, or “the company”) (NYSE: SI), a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, today 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.

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