Huaxiang Group, a leading China-based medical Additive Manufacturing provider and Dr Wang Wenjun’s Spinal Surgery team from First Affiliated Hospital of University of South China, have received Category 3 medical device clearance from China’s National Medical Products Administration (NMPA) for its titanium porous spinal fusion cages produced on Farsoon metal AM machines. Farsoon Technologies, headquartered in Changsha, Hunan, China, reports that the spinal cage is the first approved orthopaedic implant to be additively manufactured by Laser Beam Powder Bed Fusion (PBF-LB) in China.
Compared to traditional cages, the additively manufactured porous spinal fusion cage offers an advanced solution for spinal conditions, including degeneration, fractures, deformities and tuberculosis. Being one of the key medical implant products identified by the ‘3D Printing Technology Application of Personalized Implant Device’ project, the NMPA recognised that the implant showcased a combined knowledge in medical-grade material, AM, design software and medical device development & clinical application.
The 3D Printing Technology Application of Personalized Implant Device project is an initiative supported by the Ministry of Science and Technology in the “13th Five-Year Plan” led by Shanghai Jiaotong University’s Ninth People’s Hospital, with a team consisting of members from the Chinese Academy of Sciences Institute of Metal Research, South China University of Technology, Sichuan University, Xi’an Jiaotong University, Shanghai Institute of Ceramics, Hubei University, Central South University, Farsoon Technologies and Huaxiang Group.
The goal of the project is to establish and extend the application of Additive Manufacturing solutions for advanced medical devices including medical-grade material, AM machines, design software, medical device development & clinical verification and medical supply chains.
The spinal fusion cage portfolio is developed with a patient-tailored process from Dr Wang Wenjun’s Spinal Surgery team for customised volume batches. The development has taken multiple iterations of structural optimisation throughout the years, with comprehensive research over thirty mechanical properties, physical & chemical performance, biological evaluation and cytotoxicity, etc. During the clinical study phase, Dr Wang’s team conducted 108 cases in five Tertiary A hospitals across the country, before it received clearance from NMPA.
With the advanced capabilities of metal AM, Dr Wang’s team together with the Huaxiang Group, are able to create a unique lattice design similar to the trabecular micro surface structure featuring customisable pore size, porosity and elastic modulus that are close to that of human bones. It reportedly helps to reduce the tension of stress, promote bone in growth rate and long-term stability.
With substantial input from surgical design and metal Additive Manufacturing, unique geometric structures with fully-customised anatomical endplates which feature curved angles and expanded contact surface topology are able to deliver the perfect anatomical match for a wide range of complex surgical conditions. The surgeons are also said to benefit from significantly faster ‘on-demand’ development to the production cycle for a high-quality, precise product by using Farsoon Technologies’ PBF-LB machines, whereas the conventional multiple-use device usually takes months to manufacture.
“This is a ground-breaking day for metal 3D printing in the Chinese medical market,” stated Li Xinghua, head of marketing from Huaxiang Group. “I’m grateful for joining such a strong team with Dr Wang and industry Additive Manufacturing leader Farsoon Technologies for this journey. We are very proud to contribute our effort to future patient-tailored spinal implant surgeries with the application of SLM technology.”