Another Certification Secured! Xi’an Sailong Supports Mindray Orthopedics in Gaining Class III Medical Device Approval for 3D-Printed Artificial Vertebrae

On September 25, 2025, Panda3dp.com learned from Xi’an Sailong that its partner Wuhan Mindray Technology Co., Ltd. (hereafter referred to as Mindray Orthopedics) has officially received approval from the National Medical Products Administration (NMPA) for its 3D-printed titanium alloy artificial vertebral body (Registration No. Guo Xie Zhu Zhun 20253131846).

This marks the fourth Class III medical device registration jointly achieved by Xi’an Sailong and Mindray Orthopedics, following approvals for the 3D-printed acetabular cup system (No. 20233131002), 3D-printed intervertebral fusion cage (No. 20243132565), and 3D-printed self-stabilizing fusion cage (No. 20253130523). The milestone once again validates the process stability and clinical reliability of domestically developed electron beam 3D printing equipment and technology in orthopedic implant manufacturing.

Electron Beam 3D Printing: Speed, Precision, and Purity

Electron beam 3D printing technology offers significant advantages for orthopedic implants—fast production efficiency, lower manufacturing cost, no post-processing requirements, and high material purity. Since 2021, Xi’an Sailong has maintained a close, comprehensive collaboration with Mindray Orthopedics, advancing the industrial application of this technology for orthopedic devices.

Leveraging its full electron beam 3D printing ecosystem—including equipment, raw materials, and process software—Xi’an Sailong provided end-to-end technical support, assisting Mindray Orthopedics in directed product development, structural design optimization, and process parameter configuration.

The resulting implants demonstrated dimensional precision, mechanical strength, microstructure integrity, chemical composition stability, and uniform porous architecture that meet or exceed both national and industry standards, as well as Mindray Orthopedics’ internal specifications for orthopedic implants.

Mindray’s expert team, known for innovative implant design concepts and deep clinical experience, worked closely with Sailong to expand the batch application of electron beam 3D printing in orthopedic implant manufacturing.

Scaling Up: From R&D to Mass Production

Xi’an Sailong has continuously focused on advancing electron beam 3D printing in medical applications, establishing a complete innovation system—covering equipment, materials, and processes—that aligns with NMPA certification standards.

The company has partnered with over 10 domestic and international medical device enterprises, including Mindray Orthopedics, to develop and register electron beam–printed implants using titanium alloys, tantalum, and zirconium–niobium alloys. These products encompass both standardized and patient-specific solutions for hip, knee, and spinal implants.

Currently, Sailong operates a production line equipped with nearly 50 electron beam 3D printers, boasting an annual capacity of 100,000 orthopedic implants. Over the past year, more than 60,000 implants have been delivered. The company’s project, “Standardized Trabecular Hip Cup Batch Additive Manufacturing,” has been recognized by China’s Ministry of Industry and Information Technology as a typical application of additive manufacturing.

Toward the Next Frontier

Looking ahead, Xi’an Sailong will continue to collaborate with partners to advance innovation, industrialization, and application of 3D-printed orthopedic implants, driving the development of China’s medical additive manufacturing industry to new heights.