Biomaterials

Solution Provider of Medical Biomaterials

Scroll Down

Company Profile

As a subsidiary of Zhejiang Pfluon Technology Co. Ltd., Zhejiang Bio-PAEK Technology Co., Ltd. specializes in the R&D, manufacturing and sales of polymer biomaterials.

The Polymer Division of Pfluon has accumulated plenty of experience in chemical synthesis of PAEK, refining and purification, granulation and modification, injection molding and processing, profile processing, composite materials, application technology as well as other fields. On this basis, Bio-PAEK Technology has expanded the application of PAEK from industrial circle to medical biomaterials industry, thereby achieving the localization of medical biomaterials of PAEK .

Scientific Research Achievements

In 2019, Pfluon cooperated with Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Department of Chemical and Biological Engineering, Zhejiang University, Canwell MEDICAL Co., Ltd., Fudan University, Zhejiang University of Technology and Shanghai Jiao Tong University to jointly undertake the national key R&D projects of the Ministry of Science and Technology, i.e., Research and Development of Key Technologies for Mass Production of Medical PAEK Materials and Surface Biomimetic Modification Technology for Orthopedic Implants.

Therein, Pfluon is in charge of the sub-project Development of New Medical-grade PAEK Materials and Research on the Mass Production of PEEK. Four key technologies have been accomplished in this project, i.e., Precipitation and Granulation Technology in Polymeric Liquid Kettle, Key Technology of PEEK Purification, Preparation of PAEK with High Osteogenic Activity and Preparation of High-strength PAEK. Besides, it has passed nine tests of performance evaluation and biocompatibility evaluation (GB/T16886) in the standard specifications (YY0660-2008) of PEEK polymer for surgical implants. Currently, it is carrying out clinical trials of spinal fusion cage, and the project is scheduled to be accomplished in the first half of 2023.

Product Introduction

In the 1980s, orthopedics began to develop "equielastic material" femoral stem and fracture fixation plate shortly after the invention of PEEK, with a view to replace stainless steel with elastic modulus far exceeding that of human cortical bones. Since then, PEEK has come into the sight of orthopedic surgeons.

In 1998, PEEK officially became a commercial biomaterial, which was applied to plastic surgery and trauma surgery. Thanks to nearly 30 years of R&D, verification and clinical application, PAEK is increasingly applied as a biomaterial in human orthopedic implants.

Up till now, the three types of medical instruments of PEEK with large-scale clinical application cover spinal fusion cage, cerebral cranium, maxillofacial bone, dental bracket, femoral stem, iliac bone, articular process screw, bone lamella, transpedicular fixation nail, etc. New applications of orthopedic implants that are being developed and are making progress cover composite joints, 3D printed ribs, bone nail suture lines, etc. Currently, materials science, medicine, biology and kinematics as well as other interdisciplinary subjects are jointly studying PAEK biomaterials and potential applications. We believe that more PAEK will be used for human implantation.

Product Introduction

In the 1980s, orthopedics began to develop "equielastic material" femoral stem and fracture fixation plate shortly after the invention of PEEK, with a view to replace stainless steel with elastic modulus far exceeding that of human cortical bones. Since then, PEEK has come into the sight of orthopedic surgeons.

In 1998, PEEK officially became a commercial biomaterial, which was applied to plastic surgery and trauma surgery. Thanks to nearly 30 years of R&D, verification and clinical application, PAEK is increasingly applied as a biomaterial in human orthopedic implants.

Up till now, the three types of medical instruments of PEEK with large-scale clinical application cover spinal fusion cage, cerebral cranium, maxillofacial bone, dental bracket, femoral stem, iliac bone, articular process screw, bone lamella, transpedicular fixation nail, etc. New applications of orthopedic implants that are being developed and are making progress cover composite joints, 3D printed ribs, bone nail suture lines, etc. Currently, materials science, medicine, biology and kinematics as well as other interdisciplinary subjects are jointly studying PAEK biomaterials and potential applications. We believe that more PAEK will be used for human implantation.

Performance Strengths

 Performance Advantages: PAEK is one of the most comprehensive and suitable biomaterials for human implantation, and it is a gift from heaven to mankind. PAEK enjoys the following nine performance advantages in comparison with metals or other polymers.

Product Series

Implong - Long-lasting implants for a thriving future ahead.
Impshort - Short-term implants, yielding abundant results.
Oupshort - Optimized for widespread use, securing a fruitful future.

Implong CP

Implong™ Coarse Powder Series can provide raw powder for customers with granulation modification or further reprocessing.

Implong FP

Implong™ Fine Powder Series can be used for molding, 3D powder printing, spraying and unidirectional tape prepreg.

Implong GP

Implong™ Pure Granule Series can be used for profile extrusion, plastic monofilament extrusion and injection molding.

Implong CP

Implong™ Compound Granule Series can be used for profile extrusion, plastic monofilament extrusion and injection molding.

Implong SR

Implong™ Stock Shapes - Rod Series can be used for profile-forming machine.

Implong SP

Implong™ Stock Shapes - Plate Series can be used for profile-forming machine.

Implong CFC

Implong™ Continuous Fiber Composite Series can be used for molding, machine work, plastic insert molding, 3D printing, laser winding engineered shaping.

Bio-PAEK Polymer Product Series
Product Name Contact Time Design Type Product Form
Implong Over 30 days of implantation Long-term Implant Powder, Granules, Filament, Sheet, Rod
Impshort Less than 30 days of implantation Extended Contact
Oupshort Short-term Contact Partial Short-term Contact

Implong Medical Materials Classification

Brand Name  Description Naming Description Application Process Application Fields
Implong CP Series Implong™ Coarse Powder Series CP:Coarse Powder Blending modification All the medical equipment that made by granulation modification or further reprocessing
Implong FP Series Implong™ Fine Powder Series FP: Fine Powder molding, 3D powder printing, spraying and unidirectional tape prepreg Ribs, skull, joints, bone plates
Implong PG Series Implong™ Pure Granule Series PG: Pure Granule injection molding, extrusion Fixed nail
Implong CG系列 Implong™ Compound Granule Series CG: Compound Granule injection molding, extrusion Maxillofacial bone
Implong SR Series Implong™ Stock Shapes - Rod Series SR: Stock Shapes - Rod machine work vertebral body fusion cage
Implong SP Series Implong™ Stock Shapes - Plate Series SP: Stock Shapes - Plate machine work vertebral body fusion cage, cranial bones
Implong CFC Series Implong™ Continuous Fiber Composite Series CFC: Continuous Fiber Composite molding,laser winding engineered shaping , 3D printing joints, bone plates

In order to achieve commercial production, Zhejiang Bio-PAEK Technology Co., Ltd. has built PAEK R&D center, medical biomaterials laboratory, 600 square meters of class 10000 clean room, double screw granulator for imported medical materials, single screw extruder for imported medical materials, medical material annealing oven, medical PAEK unidirectional tape prepreg production line, etc. And based on the advanced hardware facilities, we has established ISO13485 quality management system.

Based on the project of “Key Technologies for Mass Production of Medical PAEK and the R&D of Surface Biomimetic Modification Technology for Orthopedic Implants” by the Ministry of Science and Technology, We will continue to conduct comprehensive testing of the performance evaluation and biocompatibility evaluation (GB/T16886) for Standard Specification for Polyether Ether Ketone Polymer for Surgical Implants in Industrialized Biomaterial Products (YY0660-2008). At the same time, we will apply for the document filing in the Medical Device Evaluation Center of the National Drug Administration. And we will cooperate with leading domestic PAEK orthopedic implant device manufacturers to make domestic medical PAEK to enter the market for services.

Enquiry Form

Fill out this field
Fill out this field