Medical-Grade Implant PEEK: Discover the Top 10 Global Suppliers

Introduction to 10 Global Manufacturers of Medical-Grade PEEK

Polyetheretherketone (PEEK) is a semi-crystalline high-performance aromatic polymer with stable chemical properties at high temperatures, excellent friction performance, good biocompatibility, mechanical strength, X-ray transparency, and non-cytotoxicity.

Synthesis and Purification of PEEK for Medical Use

PEEK synthesis involves fluoroketone and phenol-based monomers, along with catalysts like diphenyl sulfone. The resulting raw PEEK contains residual monomers, toxic additives, and by-products harmful to the human body, requiring further purification to remove impurities before being suitable for medical applications.Medical-grade PEEK is categorized into standard medical-grade PEEK and implant-grade PEEK based on purity and performance.

Standard Medical-Grade PEEK

This grade is commonly used in external fixators (e.g., orthotic braces), short-term interventional catheters, pump components, and non-implantable consumables such as dental bridge supports. These applications require PEEK materials to have specific biocompatibility, including being non-cytotoxic, hypoallergenic, and irritation-free, alongside meeting relevant physical and chemical performance standards.

Implant-Grade PEEK

As the name suggests, implant-grade PEEK is used in "implantable devices," such as orthopedic implants (e.g., spinal cages, ligament repair anchors, interface screws), neurosurgical repair materials (e.g., cranial and maxillofacial implants), and cardiovascular products (e.g., heart valves and pacemaker casings). Recently, modified PEEK has been applied in dental implants and trauma plates, demanding high mechanical performance. Implant-grade PEEK must meet stricter biocompatibility requirements, including systemic toxicity, genotoxicity, carcinogenicity, hemocompatibility, and implant response, and comply with ASTM F2026 standards.

To provide insight into the industry's landscape, here is an overview of 10 global manufacturers of medical-grade PEEK:

1. EVONIK

EVONIK was the first to develop implant-grade PEEK polymer filaments for 3D printing. Its VESTAKEEP® implant-grade PEEK has demonstrated superior performance in medical applications, offering excellent biocompatibility, stability, and ease of processing. It has become a high-performance material in medical technology.

2. SOLVAY

SOLVAY, based in Brussels, Belgium, is a multinational chemical group established in 1863. Its products, including Zeniva® PEEK, are widely used across industries. Zeniva® PEEK is biocompatible with bone-like properties, X-ray transparency, and reduced adverse reactions compared to metal implants.

3. VICTREX

VICTREX specializes in PEEK materials, leveraging extensive knowledge and experience in polymers, components, and applications. Its biocompatible PEEK-OPTIMA™ polymers are co-designed with medical device manufacturers, providing advanced solutions to accelerate product launches.

4. ZYPEEK

Founded in 2006, ZYPEEK offers pure resin and composite-modified PEEK products tailored for injection molding, extrusion, compression molding, and coating. Its FD-PEEK series includes 52 grades and can be customized to meet specific needs.

5. PEEKChina

PEEKChina specializes in high-performance engineering plastics, including industrial-grade ARKPEEK® and implant-grade AKSOPEEK®. In 2021, it initiated mass production of AKSOPEEK® and completed testing under YY/T0660-2008 standards by 2022.

6. JUNSUN

Established in 2011, JUNSUN is China’s first high-tech enterprise with R&D and production capabilities for implant-grade PEEK materials. Its NATUREGEN PEEK, certified to ISO 13485 and ISO 9001, meets YY/T 0660 and GB/T 16886 standards.

7. PFLUON

PFLUON launched its high-performance PEEK synthesis project in 2010 and entered the market in 2015. Its subsidiary focuses on domestic production of implant-grade PEEK, enhancing its applications in healthcare.

8. JUSEP

Founded in 2002, JUSEP specializes in high-performance engineering plastics, including PEEK. Its medical applications include precision instruments and bone substitutes, offering lightweight, non-toxic, and corrosion-resistant solutions with strong compatibility with human bone.

9. SHOUSU

Established in 2008, SHOUSU manufactures specialized PEEK products for medical devices, such as microwave digestion tanks, dental plates, and artificial bone components.

10. ENSINGER

ENSINGER, a German company founded in 1966, is a leader in high-performance engineering plastics. Its PEEK materials are widely used in aerospace, medical, electronics, and other industries, leveraging over 50 years of expertise.