Life cycle analysis of knee joint replacement implants

The life cycle of any orthopedic implant and joint replacements encompasses a number of subsequent steps from conception, to design, to demonstration of safety and effectiveness, to certification and commercialization. In silico models, prototyping, preclinical testing, in vivo clinical evaluation, and postmarket assessment represent just few examples. Every step is governed by regulatory bodies and specific dedicated procedures that the manufacturer must follow to ensure the safety and effectiveness of the product for the intended uses. Quality and performance can be also demonstrated following consensus standards, which ensure repeatability and comparability among the performance of different implant design in similar controlled conditions. This chapter aims at providing a general overview of the regulatory framework of Product Life Cycle in the United States and EU, as well as the most-used consensus standards for knee joint replacements and their subcomponents.