Development of Best Practices for Finite Element Analysis of Intervertebral Body Fusion

A. Baumann
U.S. Food and Drug Administration,
United States

Keywords: biomaterials, FDA, intervertebral body fusion device

Summary:

Bench tests for characterizing intervertebral body fusion device (IBFD) performance can be inconsistent. Finite element analysis (FEA) may provide a more repeatable alternative, but there are no standards or best practices for using FEA to evaluate IBFD performance. A preliminary review of FDA 510(k) submissions showed that current simulation techniques vary widely, creating additional burden for modelers and regulators. Additionally, a survey of industry representatives indicated that stakeholders desire more prescriptive methods for using FEA. Currently, a group of government, industry, and academic engineers is collaborating under the auspices of ASTM with the goal of developing FEA best practices for determining IBFD mechanical performance.