PEEK is called "the most promising material in the 21st century" by the engineering community. Today, more than 2 million products have been implanted in the human body. The material has been recognized by many medical device manufacturers and surgeons for its excellent biocompatibility, biological stability and elastic modulus close to human bones, and has been widely used in the fields of spine, neurosurgery and sports medicine. .
Polyetheretherketone (PEEK) is a special polymer with ultra-high performance developed in the late 1970s.
PEEK can stand out among many medical raw materials, which is inseparable from its own excellent characteristics.
In order to meet the increasing clinical demand for personalized PEEK implants, Apium has specially developed the FDM device M220 for 3D printing of PEEK implants. Combined with Evonik’s VESTAKEEP implant-grade PEEK filament, from R&D to production, M220 has passed the EU and US FDA testing and certification for 3D printing of medical implants.
Through the medical engineering data platform, the clinical data is transformed into 3D printing production requirements, and personalized surgical guides, external fixation stents, and internal implants and implants are provided for the clinic with the characteristics of low-cost and fast delivery, while ensuring PEEK implants The biocompatibility and clinical performance of the imported materials.
Additive manufacturing is a cost- and time-saving process for the production of individual parts and small batches. In the additive manufacturing industry, there is a special process that is very beneficial to the medical industry, that is, the fuse deposition (FDM) process. Apium M220 uses FDM process to achieve 3D printing of PEEK medical implants.
PEEK, a high-performance polymer with excellent biocompatibility, has established its position as a suitable material for permanent implants and prostheses. Evonik’s VESTAKEEP implant-grade PEEK filament is very suitable for the FDM process to meet individual clinical needs.
The FDM process can be easily integrated into the existing production process. The data used to reconstruct the defect is converted into a code, and the medical implant is printed out by Apium M220.
During the printing process of the implant, Apium M220 automatically records the temperature curve, the batch number of the PEEK filament and the orientation of the implant during the printing process. Closed-loop machine control provides high-quality implants, and an integrated camera can monitor possible problems during the printing process. This data is used for quality control. Patented temperature management, integrated air filtration system and high-quality materials selected for printing equipment provide a guarantee for the safe production and use of medical implants.
Advantages of FDM process
Taking the patient-matched skull patch as an example, it shows the time and cost saved compared with traditional machining.
In static tests, the skull implant can be loaded with 2.99 kN in a small area before the component ruptures. In a similar test, the human skull can withstand a force of 2.88 kN.
To produce patient-matched skull patches with exactly the same size and structure. Compared with traditional machining, Apium M220 3D printing has reduced working time by 83% and reduced production costs by 73%. At the same time, the printed implants are in line with Class 3 medical treatment. Standards for device implants.