Validating Requirements for Surgical Spinal Implants With Finite Element Analysis

When Spinal USA, a manufacturer and distributor of advanced surgical spinal products, designed a new series of spinal implants called vertebral body replacement (VBR) devices, they needed to meet United States Food and Drug Administration (FDA) requirements for physical laboratory testing in order to obtain approval for use. Designed to be inserted by a surgeon into a patient’s spine during a spinal fusion procedure, the VBR devices required thorough engineering testing to ensure that they were safe and effective. In order to meet the FDA requirements, Spinal USA contracted Saba Metallurgical and Plant Engineering Services (SMPES) to perform finite element analysis (FEA) of the various VBR designs using ALGOR FEA software to virtually predict the behavior of the VBR designs under the required test conditions. Through a combination of computer simulation and physical laboratory tests of prototypes, the VBR devices obtained FDA approval.