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Xi'an Sailong Assists MicroPort Orthopedics in Obtaining Class III Medical Device Registration Certificate for 3D-Printed Artificial Vertebral Body

September 25, 2025 Applications 152

Xi'an Sailong has been informed that the 3D-printed titanium alloy artificial vertebral body, developed by its partner Wuhan MicroPort Orthopedics Co., Ltd.

The 3D-printed orthopedic implant registration certificate obtained through the partnership between the company and MicroPort Orthopedics.

Xi'an Sailong has been informed that the 3D-printed titanium alloy artificial vertebral body, developed by its partner Wuhan MicroPort Orthopedics Co., Ltd. (hereinafter referred to as "MicroPort Orthopedics"), has officially received approval from the National Medical Products Administration (NMPA). Registration Certificate Number: National Medical Device Approval 20253131846.

This product marks the fourth Class III medical device registration certificate for 3D-printed orthopedic implants obtained by Xi'an Sailong in collaboration with MicroPort Orthopedics. It follows the 3D-printed acetabular cup system (National Medical Device Approval 20233131002), 3D-printed interbody fusion device (National Medical Device Approval 20243132565), and 3D-printed self-stabilizing fusion device (National Medical Device Approval 20253130523). This achievement demonstrates the process stability and clinical reliability of domestic electron beam 3D printing equipment and technology in the field of orthopedic implants.

Electron Beam Melting (EBM) 3D printing technology offers significant advantages in the manufacturing of orthopedic implants, including high production efficiency, low production costs, eliminated need for post-processing, and high material purity. Since 2021, Xi'an Sailong and MicroPort Orthopedics have engaged in comprehensive collaboration centered on applying EBM to orthopedic implants.

Leveraging its strengths across the entire EBM industrial chain, Xi'an Sailong provided one-stop services encompassing equipment, raw materials, and software/process solutions. This support assisted MicroPort Orthopedics in the exploratory phases of targeted product development, structural design, and process parameter establishment. The resulting products meet all relevant national and industry standards, as well as MicroPort Orthopedics' specific requirements for orthopedic implants, in terms of dimensional accuracy, mechanical properties, microstructure, chemical composition, pore structure characteristics, and uniformity.

The MicroPort Orthopedics team brings innovative implant design and manufacturing concepts, coupled with extensive professional clinical experience in orthopedics. Through this partnership, the two parties are continuously expanding the batch application scenarios of EBM technology in the field of orthopedic implants.

Xi'an Sailong's Electron Beam Melting (EBM) 3D Printing Production Line for Orthopedic Implants

In recent years, Xi'an Sailong has consistently focused on the R&D and application of Electron Beam Melting (EBM) technology in the medical field, establishing a comprehensive innovation system for equipment, raw materials, and processes that meets the registration and certification requirements of the National Medical Products Administration (NMPA). The company has formed collaborative partnerships with over 10 domestic and international medical device companies, including MicroPort Orthopedics, for the development and registration of EBM-produced orthopedic implants. These implants utilize materials such as titanium alloys, tantalum, and zirconium-niobium alloys, covering standardized and personalized application scenarios including hip joints, knee joints, and spinal products.

Furthermore, the company has invested in nearly 50 EBM systems to establish a production line with an annual capacity of 100,000 3D-printed orthopedic implants. Over the past year, cumulative deliveries have exceeded 60,000 units. Notably, Xi'an Sailong's "Batch Additive Manufacturing of Standardized Trabecular Acetabular Cups" was selected as a typical application scenario in the MIIT's (Ministry of Industry and Information Technology) Additive Manufacturing initiative.

Looking ahead, Xi'an Sailong will continue to work hand-in-hand with its partners to jointly advance the innovative R&D, industrial application, and development of 3D-printed orthopedic implants to new heights.