FDA classifies a shoulder-joint (hemi-shoulder) ceramic-head/metal-stem prosthesis as Class II (special controls)

1FDA places the ceramic-head hemi-shoulder prosthesis in Class II

FDA published a final order in the Federal Register classifying the shoulder joint humeral (hemi-shoulder) prosthesis built from a ceramic head and a metallic stem, cemented or uncemented, as a Class II (special controls) medical device. The special controls for this device type are named in the order and written into the codified classification.

FDA reasons that Class II gives a reasonable assurance of safety and effectiveness, and that lighter regulatory burden will bring beneficial new devices within easier reach of patients.

2Hemi-shoulder prostheses with ceramic heads

The device is the humeral (hemi-shoulder) prosthesis consisting of a ceramic head and a metallic stem, used cemented or uncemented. The special controls applicable to this device type are identified in the order and become part of the codified classification language.

3How FDA device classes work

FDA's device classification is risk-based: Class I (general controls), Class II (special controls), and Class III (premarket approval). FDA determined that classifying this device into Class II provides a reasonable assurance of its safety and effectiveness. It also states the action will enhance patients' access to beneficial, innovative devices, in part by reducing regulatory burdens.

4The conditions narrowing the scope

This order does not cover shoulder prostheses generally. It narrows the scope down to the construction.

The special controls applying to this device type are identified in the order and become part of the codified classification language. Device classification governs the regulatory pathway in the US market, so for those developing or manufacturing orthopaedic implants, the class and the applicable special controls are foundational information.