The Complex Process of Using the Interconnected Knee Arthroplasty Device Clearance Pathway.

Abstract

Background: The clearance of medical devices by the US Food and Drug Administration (FDA) has remained largely unchanged since 1976, when the Medical Device Amendments Act established a system classifying devices into 3 categories based on safety risk to the consumer. The system allows for the clearance of many orthopedics devices through the 510(k) premarket pathway, which is based on "predicate ancestors," previously cleared devices that are "substantially equivalent." Purpose: We sought to tr