Federal Register #FDA-2026-N-5830

FDA Classifies Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Prosthesis as Class II Medical Device

This FDA final order provides a regulatory update on orthopedic medical devices: - Government buyer: Food and Drug Administration (FDA), Department of Health and Human Services - Device classified: Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem prosthesis - Intended to replace the articular surface of the proximal humerus - May use ceramic materials (e.g., pyrolytic carbon) for the humeral head and metallic alloys (e.g., cobalt-chromium-molybdenum) for the stem - Can be fixed with or without bone cement - Classification: Class II medical device with special controls - Special controls include requirements for clinical data, non-clinical performance testing, biocompatibility, sterility, shelf life, and labeling - No specific OEMs or vendors are named; the order applies to all manufacturers of this device type - Notable requirements: - Devices must meet detailed safety and effectiveness standards - Special controls are designed to facilitate patient access and reduce regulatory burdens for innovative orthopedic devices

Description

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). This classification provides reasonable assurance of safety and effectiveness of the device and aims to enhance patient access to innovative devices by reducing regulatory burdens. The device is intended to replace the articular surface of the proximal end of the humerus and can be fixed with or without bone cement. The classification includes special controls such as clinical data, non-clinical performance testing, biocompatibility evaluation, and labeling requirements.

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