Metallic reverse shoulder prosthesis cup

A metallic reverse shoulder prosthesis cup is a sterile, metal component designed to be part of a reverse shoulder replacement system. It is intended to attach to a humeral stem or humeral body and articulate with the reverse shoulder head to restore joint function in patients with severe shoulder arthritis or rotator cuff deficiency.

Devices in this category are regulated as implantable medical devices and are typically supplied in a sterile condition for single-use during surgical implantation. They are subject to regulatory requirements for materials, biocompatibility, sterility, and performance, and are classified based on their intended use and risk profile in accordance with applicable medical device regulations.