On February 28, 2022, the Center for Device Review of the State Food and Drug Administration issued a notice on the guidelines for the registration review of additively manufactured polyetheretherketone implants (No. 3 of 2022): In order to further standardize the additive manufacturing of polyetheretherketone implants For the management of imported materials, the Device Review Center of the State Drug Administration organized and formulated the "Guidelines for the Registration Review of Additive Manufacturing Polyetheretherketone Implants", which was issued by the Medical Device Technology Review Center of the State Drug Administration.center.

This guideline is applicable to passive implantable medical devices produced by 3D printing process using PEEK material and acting on bone, joint and oral hard tissue. Preparation and writing of registration application materials, and also provide technical reference for the review of registration application materials by the technical review department.

PEEK implants

         Polyetheretherketone implants printed with Apium M220

The Apium M220 is a 3D printer designed for the manufacture of medical products and PEEK implants. Personalized orthopaedic implants can be produced by 3D printing to meet clinical and scientific needs (material engineering, biological tissue engineering).

Focusing on medical and industrial digitalization products and services.The company provides solutions and one-stop services from R&D and design to digital production for domestic and international customers in the industrial, automotive, research and medical fields.