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Farsoon receives NMPA certification for 3D printed tantalum interspinal fusion cage

Making the Huaxiang Group company the first in China to receive such accreditation

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Huaxiang Group, a leading 3D printing solutions provider specializing in the medical industry, has received Category 3 medical device clearance from the National Medical Products Administration (NMPA) for its additively manufactured tantalum interspinal fusion cage produced on a metal laser PBF 3D printer from Chinese AM hardware OEM Farsoon. This marks the first NMPA-approved tantalum orthopedic implant created using metal powder bed fusion technology in China.

Tantalum is a specialized metal material with exceptional biological inertness and compatibility, stable chemical properties, and abrasion resistance, making it an ideal material for medical implants. Since its first use in orthopedics in the 1940s, tantalum has been utilized in various medical devices for nearly eight decades.

Processing pure tantalum material for medical applications presents significant challenges due to its extremely high melting point (over 3,000°C), high density (16.6 g/cm3), and elastic modulus (185.7 GPa). For the past 50 years, conventional metal tantalum parts have been manufactured through complex processes, including powder metallurgy or electron beam melting, deformation, welding, and heat treatment.

As the market continues to demand new designs and advanced manufacturing for tantalum orthopedic products, such as femoral head repair, cranial implants, and joint prosthetics, the porous structure of tantalum implants has been clinically proven to reduce stress while providing sufficient mechanical strength. This structure also encourages bone and vascular tissue growth into the porous structure. Chemical vapor deposition processes were developed to produce commercial porous tantalum implants for medical use; however, these processes are limited to producing standard end products at a high manufacturing cost.

Farsoon, part of Huaxiang Group, receives NMPA certification for 3D printed tantalum interspinal fusion cage.
Tantalum interspinal fusion cage with porous structures designed for 3D printing.

Compared to previous manufacturing processes, the Farsoon 3D printed tantalum porous interspinal fusion cage solutions, developed by Huaxiang Group, offer numerous unique advantages across the design and manufacturing stages. These additively manufactured implants can be fully customized and produced according to patients’ conditions, with the trabecular microstructure achieving 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 the human cancellous and trabecular bone – providing excellent stability, biomechanical compatibility, and reduced stress shielding. Precision production using digital models allows for high size accuracy, internal structure, and designated roughness with minimal post-processing required. Furthermore, these implants have excellent load-bearing capabilities, with the additively manufactured implant ready for immediate load-bearing and exhibiting high toughness, good plasticity, and fatigue resistance. This approach also promotes sustainable manufacturing with high material utilization, improved efficiency through optimized manufacturing workflow, and reduced part lead time and cost.

Through years of technological innovation and clinical practice in the medical field, Farsoon has achieved numerous milestones in additive manufacturing applications, including, according to Farsoon, the world’s first knee replacement surgery using a 3D printed tantalum implant, in 2017; the world’s first 3D printed implant surgery using degradable zinc alloy material, in 2020; the first NMPA-approved porous titanium spinal fusion cage built by powder bed fusion technology, in 2021; and NMPA-approved porous titanium interspinal fusion cage, in 2022; and more than 14,000 customized surgical guide cases by the end of January 2023.

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Edward Wakefield

Edward is a freelance writer and additive manufacturing enthusiast looking to make AM more accessible and understandable.

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