HHS FDA Classifies Hemi-Shoulder Ceramic Head Prosthesis as Class II Device
June 06, 2026
June 06, 2026
WASHINGTON, June 6 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying a shoulder joint humeral, or hemi-shoulder, ceramic head and metallic stem prosthesis into Class II with special controls, establishing a regulatory framework that the agency said provides reasonable assurance of safety and effectiveness while supporting access to orthopedic devices.
The device is designed to replace the articular surface a . . .
The device is designed to replace the articular surface a . . .