FDA regulatory considerations for innovative orthopedic devices: A review.

Abstract

Novel and innovative orthopedic devices are needed to address clinical challenges in orthopedic practice. Obtaining regulatory authorization for such devices, however, can prove challenging. An inherent dilemma exists between innovation to address unmet needs and imitation to demonstrate substantial equivalence to a predicate device, which is required for the less burdensome 510(k) pathway. This article provides both an overview of highly innovative orthopedic devices over the last 10 years as w