Production Status of Titanium Alloy Materials for Medical Devices in China

So far, pure titanium and TC4 titanium alloy remain the world's largest and most widely used traditional surgical implant materials, accounting for over 80% of the global biomedical titanium alloy market. Currently, the processed titanium and titanium alloy materials for surgical implants produced in China include plates (thickness 0.8-25mm), bars, and wires (diameter 1-90mm). The supply conditions can be cold-rolled, hot-worked, and annealed.

Currently, the microstructures of TC4, TC4ELI, and TC20 titanium alloy additives are rated according to GB/T 13810-2007 using the microstructure rating charts provided in Appendix A, which are sourced from YY/T 0512-2009 / ISO 20160:2006, "Classification of Microstructures of α+β Two-Phase Titanium Alloy Bars for Metal Surgical Implants." Due to the different processing techniques for titanium alloy plates and bars, the microstructure charts specified in Appendix A only apply to the rating of α+β two-phase titanium alloy bars and not to the rating of α+β two-phase titanium alloy plates.

Although Chinese national standards clearly stipulate that the microstructure grade types of TC4 and TC20 titanium alloys should conform to the A1-A9 α+β two-phase microstructure, most domestic titanium alloy materials exhibit microstructures in the A3-A5 grade, with relatively poor quality stability upon supply. In contrast, titanium materials imported from the United States can achieve microstructures as fine as A1-A3 grade, and small bars with diameters less than 15mm can achieve an A1 grade (equiaxed α and β phase grain size less than 10μm), thereby offering good strength, toughness, corrosion resistance, and mechanical machinability. Consequently, China still requires significant imports of high-quality TC4 titanium alloy materials to process high-end medical devices such as artificial joints, dental implants, and spinal internal fixation systems. Domestic medical titanium materials, on the other hand, primarily meet the demand for mid- to low-end medical devices such as bone plates and screws.