The Food and Drug Administration (FDA) is classifying the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · June 05, 2026
FDA Classification of Shoulder Joint Humeral Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis as Class II
Original title: Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
FDA classifies shoulder joint humeral ceramic head/metallic stem prosthesis into Class II with special controls to ensure safety and effectiveness.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.