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U.S. Food and Drug Administration

Additively Manufactured Titanium – 6 Aluminum – 4 Vanadium Material Models

Catalog of Regulatory Science Tools to Help Assess New Medical Devices 

This regulatory science tool (RST) is a series of quasi-static isotropic material models for additively manufactured (AM) Titanium – 6 Aluminum – 4 Vanadium (Ti-6Al-4V) for use in finite element or other engineering analysis techniques.

Technical Description

This RST is a dataset of seven material models for AM Ti-6Al-4V for use in engineering applications such as finite element analysis (FEA). The dataset spans a percentile range for tensile data of AM Ti-6Al-4V that has been hot isostatically pressed (HIPed) per ASTM F3001 [1]. The seven material models are provided in tabular form as pairs of True-Stress and Plastic-Strain data along with other key material properties. 

Intended Purpose 

The intended purpose of this RST is to provide material models of HIPed AM Ti-6Al-4V for use in finite element analysis simulations. The quasi-static tensile mechanical properties of AM Ti-6Al-4V have been shown to have greater variability than non-AM Ti-6Al-4V making it challenging for designers to estimate the expected performance of an AM device. These methods and models are based on a range of percentiles observed from a pool of HIPed AM Ti-6Al-4V quasi-static tensile data. These models may be used by designers to simulate device performance across a range of possible material behaviors. 

These tabular data sets can be used to create multilinear isotropic models in the user’s finite element analysis software. Device designers may use the material models to simulate a range of mechanical responses of AM Ti-6Al-4V medical devices, drawing on data from multiple AM contract manufacturers. 

Testing

The RST was assessed using published data from 223 tensile tests performed on HIPed AM Ti-6Al-4V samples from seven manufacturers to develop the set of material models [2]. Per the publication, the tensile data were converted to true stress-strain values and at each percentile a true stress-strain curve was constructed. 

Limitations

  • These material models were derived from a set of axial tensile coupons built in the Z-direction made from seven vendors with multiple builds per vendor included.  However, this data set could not cover all AM and post-processing variables.  
  • Material models derived from the specific AM system used to fabricate a device may more closely reflect the properties of that particular process. 
  • The material models may be a more conservative or less conservative estimate of material behavior relative to the data observed for the seven vendors.  
  • Compressive performance of Ti-6Al-4V may be different than tensile performance. 
  • These models are designed for use in simulating monotonic loading and have not been tested in cyclic, fatigue, unloading, creep, stress relaxation, or high temperature scenarios. 
  • Additional technical details on methodology and constraints is provided in the supporting publication [2].

Supporting Documentation

[1] ASTM, ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. https://doi.org/10.1520/f3001-14r21

[2] Tetteh, A., Kadakia, J., Schwerin, M. et al. Static Variability and Proposed Plastic Material Models in Additively Manufactured Laser Powder Bed Fusion Ti6Al4V. J. of Materi Eng and Perform (2026). https://doi.org/10.1007/s11665-026-13480-3

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