Titanium spinal fusion cage produced on Farsoon AM machine receives China’s NMPA clearance

March 3, 2021

The NMPA approved porous spinal fusion cage additively manufactured on a Farsoon metal AM machine (Courtesy Huaxiang Group)

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.

The additively manufactured porous spinal fusion cage portfolio featured with a variety of geometries structures (Courtesy Huaxiang Group)

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.”

www.farsoon.com

About Metal Additive Manufacturing magazine

Metal AM magazine, published quarterly in digital and print formats, is read by a rapidly expanding international audience.

Our audience includes component manufacturers, end-users, materials and equipment suppliers, analysts, researchers and more.

In addition to providing extensive industry news coverage, Metal AM magazine is known for exclusive, in-depth articles and technical reports.

Our focus is the entire metal AM process from design to application.

Each issue is available as an easy-to-navigate digital edition and a high-quality print publication.

In the latest issue of Metal AM magazine

Download PDF
 

Extensive AM industry news coverage, as well as the following exclusive deep-dive articles:

  • Fly-by-wire: How Additive Manufacturing took to the skies with Norsk Titanium
  • Dynamic beam shaping: Unlocking productivity for cost-effective Laser Beam Powder Bed Fusion
  • Enabling the fusion energy revolution: Mastering tungsten with PBF-EB Additive Manufacturing
  • Patents and Additive Manufacturing: What insights can mining PBF-EB data reveal about the industry and the technology?
  • Additive Manufacturing for Semiconductor Capital Equipment: Unlocking critical supply chains
  • Can Additive Manufacturing lower the carbon footprint of parts for the energy and maritime industries?
  • Inspect Additive Manufacturing, stop monitoring: Phase3D’s unit-based, in-process inspection solution for powder bed AM

The world of metal AM to your inbox

Don't miss any new issue of Metal AM magazine, and get the latest industry news. Sign up to our twice weekly newsletter.

Sign up

Looking for AM machines, metal powders or part manufacturing services?

Discover suppliers of these and more in our comprehensive advertisers’ index and buyer’s guide, available in the back of Metal AM magazine.

  • AM machines
  • Process monitoring & calibration
  • Heat treatment & sintering
  • HIP systems & services
  • Pre- & post-processing technology
  • Powders, powder production and analysis
  • Part manufacturers
  • Consulting, training & market data
View online

Discover our magazine archive…

The free to access Metal Additive Manufacturing magazine archive offers unparalleled insight into the world of metal Additive Manufacturing from a commercial and technological perspective through:

  • Reports on visits to leading metal AM part manufacturers and industry suppliers
  • Articles on technology and application trends
  • Information on materials developments
  • Reviews of key technical presentations from the international conference circuit
  • International industry news

All past issues are available to download as free PDFs or view in your browser.

Browse the archive

Share via
Copy link
Powered by Social Snap