Farsoon-Printed Spine-Cage Implants Earn Chinese Clearance

March 8, 2021
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Huaxiang Group, a provider of 3D-printed medical components, and Dr. Wang Wenjun’s Spinal Surgery team from First Affiliated Hospital of University of South China, recently received Category 3 medical-device clearance from China’s National Medical Products Administration (NMPA), for its porous spine-fusion cages, produced on metal-additive manufacturing (AM) systems from Farsoon Technologies, represented in North America by Farsoon Technologies Americas, Round Rock, TX. This marks the first approved orthopedic implants built via metal laser powder-bed fusion technology in China, according to Farsoon officials.

This titanium cage represents an advanced solution over traditional trimmed cages and anatomical cages for treatment of spinal conditions such as degeneration, fractures, deformities and tuberculosis. It is identified as one of the key medical-implant products identified by the 3D Printing Technology Application of Personalized Implant Device project headed by China’s leading hospitals, research institutes, material manufacturers and 3D-printing specialists. NMPA approval recognizes project partners’ combined knowledge in medical-grade material, AM, design software, medical-device development and clinical application.

“This is a ground-breaking day for metal 3D printing in the Chinese medical market,” says Li Xinghua, Huaxiang Group’s head of marketing. “I’m grateful for joining a such strong team with Dr. Wang and Farsoon Technologies for this journey. We are very proud to contribute our effort to future patient-tailored spinal implant surgeries with the application of selective-laser-melting technology.”

The spine-fusion-cage portfolio has been developed as a patent-tailored process for customized volume batches, employing multiple iterations of structural optimization through years of development. This has included comprehensive research related to more than 30 mechanical properties, physical and chemical performance, biological evaluation and cytotoxicity, and more. During the clinical studies, Wang’s team conducted 108 cases in five Tertiary A hospitals across China before the portfolio received NMPA clearance.

Via the capabilities of metal AM in general and Farsoon’s AM technology in particular, Wang’s team along with Huaxiang Group can create a unique lattice design featuring customizable pore size, porosity and elastic modulus that resemble that of human bones. This helps to reduce stress tension, promote bone growth and achieve long-term stability. The portfolio, thanks to forward surgical-design thinking and the capabilities inherent in metal AM, offers unique geometries and structures with fully customized anatomical endplates that feature curved angles and expanded contact-surface topology. The result: perfect anatomical matches for a wide range of complex surgical conditions, according to project partners.

Surgeons also benefit from a significantly faster development-to-production cycle and high-quality, precise end products through the use of Farsoon laser powder-bed fusion systems, according to Farsoon officials, whereas conventional multiple-use devices typically take months to manufacture via traditional processes. 
Industry-Related Terms: LASER
View Glossary of Metalforming Terms

 

See also: Farsoon Technologies

Technologies: Additive Manufacturing

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