Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
Key claim: The FDA is classifying the shoulder joint humeral ceramic head/metallic stem cemented or uncemented prosthesis into class II (special controls) to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Classifying this shoulder prosthesis as Class II with special controls establishes a defined regulatory pathway for manufacturers, likely via 510(k) clearance rather than more burdensome premarket approval. For patients and orthopedic providers, this can improve access to hemi-shoulder replacement options while maintaining safety and effectiveness standards.