Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Sh
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 cl
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Rule |
| Published | 2026-06-05 |
| Summary | 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 de |
| Document number | 2026-11306 |
| Official record | https://www.federalregister.gov/documents/2026/06/05/2026-11306/medical-devices-orthopedic-devices-classification-of-the-shoulder-joint-humeral-hemi-shoulder |