Domestic First! PEEK Material Application Reaches New Milestone

On December 30, Evonik announced a significant update, revealing that its patient-matched cranial repair prosthesis, developed in collaboration with Tianjin Kang'er Medical Devices Co., Ltd., has been officially approved for market launch by the National Medical Products Administration. This approved product is not only the first personalized cranial repair prosthesis registration certificate in China based on FDM (Fused Deposition Modeling) additive manufacturing technology, but it also innovatively utilizes PEEK (Polyether Ether Ketone), a high-performance biomedical material. This marks a key milestone in the application of PEEK materials in the 3D printing field for neurosurgical implants and opens a new era of "precise integration" for cranial repair in China.

The recently approved cranial repair prosthesis features the use of Evonik's implant-grade bone-integrating PEEK filament VESTAKEEP® Fusion iC4800 3DF, manufactured through FDM technology. PEEK, known as the "ideal material close to human bone," is a high-performance polymer material with inherent advantages such as an elastic modulus matching that of human cranial bone, excellent tissue compatibility, and good imaging compatibility. This innovative application further enhances these advantages: compared to traditional cranial repair materials and processes, this PEEK prosthesis achieves multiple key upgrades.

In terms of performance, leveraging the biomechanical characteristics of PEEK material, its mechanical and biological properties precisely match clinical needs, providing long-term stable and reliable protection for brain tissue. In terms of design, PEEK material can overcome the limitations of traditional machining processes and sheet thickness through 3D printing, enabling the precise customization of complex porous structures and personalized anatomical shapes, perfectly fitting the patient's cranial defect area. In terms of clinical value, with the biocompatibility advantages of PEEK material, it can significantly reduce surgical complexity and postoperative rejection risks, while enhancing postoperative adaptability, thereby greatly improving the patient's postoperative experience and quality of life.

Zhang Jinhong, Vice President and General Manager of Evonik's High Performance Polymers Business Line in the Asia-Pacific region, pointed out that PEEK materials are key to unlocking the potential of additive manufacturing technology in the medical device field. Evonik's implant-grade PEEK and its composite filaments, developed specifically for additive manufacturing, are continuously unleashing this potential.

"The successful collaboration with Koner Medical has enabled us to achieve truly personalized PEEK implant solutions in neurosurgery." He particularly emphasized that the innovative application of PEEK filament combined with FDM technology not only maximizes the performance advantages of PEEK materials but also effectively addresses the industry pain point of low material utilization in traditional PEEK sheet machining. In the future, Evonik will continue to delve into PEEK material technology innovation, join forces with industry partners, and promote more innovations in additive manufacturing in the medical field to benefit more patients.

This breakthrough is not accidental, but rather another important achievement resulting from Evonik's continuous efforts in the medical applications of PEEK materials. As early as 2024, Evonik's globally first implant-grade PEEK filament VESTAKEEP® i4 3DF obtained the first NMPA registration certificate in the spinal field. The approval of the cranial repair product once again confirms the feasibility and superiority of using PEEK materials combined with FDM technology in implant-grade medical device applications. In addition to the bone-bonding filament VESTAKEEP® Fusion iC4800 3DF applied in this instance, Evonik also offers a rich product line including the carbon fiber reinforced PEEK filaments VESTAKEEP® iC4612 3DF and VESTAKEEP® iC4620 3DF.

As a local enterprise focused on medical technology research and development, Ma Zhe, the deputy general manager of Kang'er Medical, stated that the company has always been guided by clinical needs, directly addressing the shortcomings of traditional cranial repair materials in terms of tissue integration and fit precision. The characteristics of PEEK materials provide core support for solving these pain points. "After thousands of experimental optimizations, we have finally developed this PEEK composite prosthesis containing biphasic calcium phosphate, and innovatively adopted FDM 3D printing to achieve fully personalized customization."

Compared to traditional PEEK materials, the Kang'er 4D pro PEEK prosthesis further enhances the material's bone integration capabilities, achieving a qualitative leap in tissue compatibility, bone integration efficiency, and adaptation precision. Its launch not only highlights the breakthroughs of local enterprises in PEEK material modification and application processes but also marks China's official entry into the "precision integration" era of cranial repair.

As a global chemical company headquartered in Germany, Evonik continually surpasses the boundaries of chemistry with its innovative strength and leading technological expertise, with business operations spanning over 100 countries and regions. In 2024, Evonik achieved sales of 15.2 billion euros and operating profit (adjusted EBITDA) of 2.1 billion euros. This cross-border collaboration with Conler Medical is a vivid embodiment of Evonik's philosophy of "surpassing the boundaries of chemistry, leading a better future" in the medical field.