NMPA Certifies Farsoon 3D Printed Tantalum Interspinal Fusion Cage

Huaxiang Group, a 3D printing solution provider with expertise in the medical industry, has received the category 3 medical device clearance from China’s National Medical Products Administration (NMPA) for its tantalum fusion cage additively manufactured on a Farsoon metal machine. The company says it is the first NMPA-approved tantalum orthopedic implant built by metal powder bed fusion technology in China. 

Known as a specialized metal material with excellent biological inertness and compatibility, stable chemical properties and abrasion resistance, the tantalum metal material is well suited for medical implants. Since its first use in orthopedics in the 1940s, the tantalum has been used in many kinds of medical devices for nearly 80 years. 

Due to the extremely high melting point (over 3,000°C), high density (16.6 g/cm3) and elastic modulus (185.7 GPa), the pure tantalum material can be quite challenging to process for use in the medical field. In the past 50 years, the conventional metal tantalum parts were manufactured through a complicated process — powder metallurgy or electron beam melting, deformation, welding and heat treatment. 

With the application development of tantalum orthopedic products such as femoral head repair, cranial implant and joint prosthetics, the market has kept pushing the new designs and advanced manufacturing. It is said the tantalum implant with porous structure is proved in clinical practices to reduce stress while providing sufficient mechanical strength. It also encourages bone and vascular tissue growing into the porous structure. The chemical vapor deposition process was then developed for producing commercialized porous tantalum implants for medical use. However, with the limitation of the technology, it is only able to deliver standard end products, with a high manufacturing cost. 

Compared to the previous manufacturing processes, Farsoon 3D printed tantalum porous interspinal fusion cage solutions developed by Huaxiang Group offers many advantages from design to manufacturing:

• The additively manufactured implants can be fully customized and produced according to patients’ conditions. The trabecular microstructure can achieve a high porosity of 68-78% to promote bone tissue and vessel fusion. 
• The elastic modulus of the 3D printed tantalum implant is highly comparable to human cancellus and trabecular bone. It offers excellent stability, biomechanical compatibility and reduced stress-shielding. 
• Precisely produced using the digital model, the implants can achieve high size accuracy, internal structure and designated roughness which only require minimal postprocessing. 
• Excellent load-bearing capability. The additively manufactured implant is ready for immediate load-bearing with high toughness, good plasticity and fatigue resistance. 
• Sustainable manufacturing with high material utilization.
• Improved efficiency with optimized manufacturing workflow. 
• Reduced part lead time and cost.

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