U.S. Food & Drug Administration,
Keywords: spinal fusion, finite element analysis
Summary:Bench tests for characterizing spinal fusion cage performance can be inconsistent. Finite element analysis (FEA) may provide a more repeatable alternative, but there are no standards or best practices for spinal fusion cage FEA. 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 spinal fusion cage mechanical performance.