Spine Products in Use Both Outside and Inside the United States

Abstract

The spine product market in the United States and that of the rest of the world shares many similarities but also has significant differences. The FDA approval process of medical devices in the United States has a more stringent, often inconsistent, and prolonged pathway to final approval than when compared to the CE marking process in Europe. In fact, a large number of spinal implants have not yet been either approved or used as widely in the United States as compared to the rest of the world. There are three main spine product categories, namely lumbar artificial discs, interspinous spacers, and dynamic stabilization systems that can be identified as "new" and not as widely used in US markets. After analyzing why some of the products in these categories failed the FDA approval process, we present other unique spine products widely used in European and other international markets but not so commonly seen in US markets.