In September 2021, the National Medical Products Administration (NMPA) formally approved the marketing application of the "3D printed titanium alloy interbody fusion cage". The product was developed and clinically verified by Zhongnuo Hengkang for six years and completed the independent intellectual property rights. The marketing registration approval of innovative products has further expanded the medical market for metal 3D printing products, promoted the commercialization of 3D printed titanium alloy spinal implants, and facilitated its clinical application in degenerative spinal diseases.
Additive Manufacturing (Additive Manufacturing) technology, also known as 3D printing technology, uses three-dimensional digital model data as a template to manufacture products by gradually increasing raw materials, which is different from the traditional subtractive manufacturing process. The titanium alloy interbody fusion cage, which is additively manufactured using Electron Beam Melting EBM, has a porous bionic bone trabecular structure, which is designed to mimic natural bones and help promote spinal intervertebral fusion.
In the process of spine intervertebral fusion, the degenerated and collapsed intervertebral disc is taken out and replaced with an intervertebral fusion cage and bone graft; the intervertebral fusion cage can restore the height of the vertebrae, provide initial stability for the diseased vertebra, and provide bone graft fusion Conditions to improve the fusion rate. Since the human vertebral body is mainly composed of cortical bone and cancellous bone, there are significant differences in composition, pore size, and tissue density between the two. The bone density on the surface of the vertebral body of the spine is thin, and the inside is mainly loose cancellous bone. . Our 3D printing technology allows the intervertebral fusion cage to have a porous structure by controlling the pore parameters so that it has a certain elastic modulus while increasing the penetration rate of bone tissue. All these features help to promote bone fusion and reduce the loosening of the fusion cage. And related complications such as loss of intervertebral height.
Features and advantages of 3D printed titanium alloy interbody fusion cage
1. Macrostructure
Has good mechanical strength, corrosion resistance, and biocompatibility.
By adjusting the size of the micro-holes, the 3D printed titanium alloy intervertebral fusion cage has an elastic modulus close to that of the cortical bone and cancellous bone of the vertebral body.
The 3D printed titanium alloy intervertebral fusion cage conforms to the anatomical shape of the upper and lower endplates between the vertebral bodies, which facilitates full contact with the upper and lower endplates, is convenient to insert, has good initial stability, and does not need to worry about cage displacement.
The surface roughness process makes this product have micron and nanometer surface roughness, which can maximize the mutual anchoring of bone and implant surface, thereby improving osseointegration. Studies have shown that surface roughness has a beneficial effect on cell differentiation and proliferation.
2. Microstructure
The porosity of human cortical bone is 5-10%, while the porosity of cancellous bone is 75%-90%. The cancellous bone is highly porous and is made up of closely connected pores with diameters ranging from 300-1000μm.
Current studies believe that the minimum pore size that allows bone tissue ingrowth is 100μm, the critical size for capillary formation is 300-400μm, and the bone ingrowth effect has a better performance when the pore size is in the range of 300-1000μm, and the porous titanium structure has pores. The interconnection is conducive to bone growth.
In vitro studies have shown that human stem cells cultured on a similar porous titanium structure have greater osteoblast differentiation ability than solid titanium surfaces.
This product has a titanium alloy bionic bone trabecular structure with a design porosity of 70-80% and a pore diameter of 300-800um. It can effectively provide pores for bone tissue growth and a surface that is good for cell adhesion and is good for new bone to grow through the micropores. It enters into the fusion cage and adheres to the surface of the metal trabecular bone to form a tight combination of bone and endophyte.
3. Excellent visualization
High radiographic visibility can achieve a better outline display, which is convenient for clear observation of the fusion cage during and after the operation, evaluation of the contact between the vertebral endplate and the implant, and the bone fusion.
The implant is clearly visible in X-rays, CT scans have no scattered, MRI artifacts are reduced, and there is no scatter from tantalum markers.
4. Clinical application
The good titanium alloy bionic bone trabecular structure design eliminates the need for bone grafting (no bone graft window) inside the fusion cage. Animal experiments and clinical trials have shown that this product can allow adjacent bone tissues to grow into it freely, and ultimately achieve bone fusion.
The design without a bone grafting window facilitates surgical operation, reduces the possibility of the fusion cage being contaminated, thereby reducing the probability of surgical infection.
This product has complete models and specifications, which can not only meet the needs of cervical and lumbar intervertebral fusion surgery but also meet the needs of ALIF, TLIF, OLIF, and other surgical methods.
Contact Us
Baoji Jufuti Non-ferrous Metals co,Ltd.
Email: sales1@bjjfti.com
Telephone: +86 917-3158689
Mobile: +86 13892777995
Address: Gaoya Industrial Park, Gaoya village, Bayu Town, high-tech Development Zone, Baoji City, Shaanxi Province，China.
