EVONIK VESTAKEEP® PEEK - High-performance polyether ether ketone materials for medical applications

As the technology leader for high-performance polymers, we supply polyether ether ketone molding materials for the medical sector. Our VESTAKEEP® grades for implants, dental applications and medical devices are changing standards for medical technology applications due to their outstanding biocompatibility and biostability.

VESTAKEEP® PEEK - NEXT GENERATION medical MATERIAL with strong features

Polyether ether ketone has been used in medical implant applications for years. VESTAKEEP® PEEK is the latest product line meeting the unmet needs in these medical applications.

Main characteristics of VESTAKEEP® PEEK

• excellent biocompatability
• resistance to all common used sterilization methods
• high gamma radiation resistance
• excellent fatigue properties
• unique ductility characteristics
• mechanical properties close to cortical bone
• high chemical resistance
• high resistance to desinfection and sanitizing agents
• very good resistance to wear
• high dimensional stability
• excellent biostability
• high creep resistance
• good electrical insulation properties
• good thermal insulation properties

High performance for various medical application areas

Due to its impressive properties, VESTAKEEP® PEEK biomaterials can be used in a number of different medical application areas, such as:

• Dental Care
• Orthopedics
• Cranio-Maxillo-Facial (CMF)
• Medical equipment

Four VESTAKEEP® PEEK grades for best performance in medical implants, dental applications and medical equipment

We offer PEEK solutions for long term implantable medical devices (implant-Grade), for permanent mucous membrane contact (Dental-grade) and for short time contact to human blood, tissue or bone for up to 30 days (Care-Grade).

• VESTAKEEP® Implant
  Long term - especially designed for long term implantable medical devices
• VESTAKEEP® Fusion
  Our PEEK solution with biphasic calcium phosphate (BCP) as functional additive for osteoconductive properties and accelerated bone healing
• VESTAKEEP® Dental
  Permanent mucous membrane contact - especially designed for removable and fixed dentures, crowns and bridges
• VESTAKEEP® Care
  Short time contact to human blood, tissue or bone for up to 30 days – especially designed for medical equipment

VESTAKEEP® Implant

VESTAKEEP® Fusion

VESTAKEEP® Dental

VESTAKEEP® Care

Injection molding

At Evonik, one of the key technologies we use to manufacture our medical equipment products is injection molding. Injection molding is a process that involves melting plastic pellets and injecting them into a mold cavity under high pressure. The mold cavity is shaped like the desired product, and the plastic solidifies as it cools down. Injection molding allows us to produce complex and precise shapes with minimal waste and high efficiency.

Evonik offers a comprehensive range of biomaterials that are specifically designed for the production of high-quality injection molded medical device parts, suitable for both temporary and permanent body contact.

Our VESTAMID® compounds are tailored for precision injection molding, enabling the manufacture of complex components ranging from miniature parts to highly filled fittings. These compounds can be processed on standard injection molding machines, affirming their versatility and ease of use in commercial production settings.

For applications demanding the highest level of performance, our VESTAKEEP® PEEK polymers and compounds are the materials of choice. They are processed primarily in granular form for injection molding and extrusion, with powder grades available for specialized applications such as coatings, laser sintering, and compression molding. Our state-of-the-art test centers are fully equipped to ensure that VESTAKEEP® meets the stringent requirements of the medical industry.

TROGAMID® Care, known for its excellent thermal resistance, provides a broad processing window. This material is suitable for both injection molding and extrusion, and our expert teams are ready to support you with the knowledge gained from our extensive testing and development efforts.

Additionally, our RESOMER® line of bioresorbable polymers demonstrates our advanced expertise in processing conditions for injection molding. RESOMER® is engineered to be easily processed using standard injection molding technologies, making it an ideal choice for creating bioresorbable medical devices with precise mechanical properties.

Extrusion

Extrusion is a method of shaping materials by forcing them through a die or a nozzle under high pressure and temperature. Extrusion can produce various shapes and sizes of products, such as tubes, rods, wires, films, sheets, and profiles.

Evonik's extrusion process expertise is exemplified through our VESTAMID®, VESTAKEEP®, TROGAMID® Care and RESOMER® product lines, designed to meet the rigorous demands of medical device manufacturing.

VESTAMID® compounds are engineered for versatility, enabling the production of high-quality profiles, tubing, including multilayer tubing, and other complex extruded shapes. These materials are optimized for conventional three-zone screws with a minimum length of 24 D, ensuring smooth processing and top-tier product outcomes. Additionally, alternative screw designs like barrier screws can be employed for specialized extrusion requirements, further showcasing our adaptability in process technologies.

For the most demanding medical applications, our VESTAKEEP® PEEK polymers and compounds stand out with their exceptional performance. Suitable for injection molding and extrusion, these PEEK materials are primarily processed in granular form, with powder grades available for coatings, laser sintering, and compression molding. Our advanced test centers are fully equipped to handle all common processes, ensuring that VESTAKEEP® meets the highest standards for medical technology.

TROGAMID® Care is another example of Evonik's superior biomaterials, offering remarkable processing flexibility and thermal resistance, making it ideal for both injection molding and extrusion applications. Furthermore, our RESOMER® portfolio, known for its advanced processing capabilities, is easily adaptable to standard extrusion technologies. It allows for the creation of bioresorbable medical devices with precise mechanical properties to match the specific needs of various medical applications. For RESOMER®, we offer both standard and customized filaments.

Our customized filaments are meticulously crafted to order, drawing from the extensive RESOMER® portfolio to match your exact specifications for performance and functionality. Moreover, we specialize in creating tailor-made components, including sheets, ribbons, and bars, all designed to integrate seamlessly with your medical devices or applications.

Evonik's comprehensive processing services, including material selection, preparation, and equipment setup, are tailored to support the development and optimization of your medical devices. Whether you require monofilament for medical textiles or complex extruded components, we are equipped to assist you from concept to commercialization.

VESTAKEEP^® PEEK

Quality and approvals

Evonik has established a product portfolio that is build on the specific quality, process and performance requirements demanded by the medical industry.

Our quality system based on ISO 9001:2008 ensures a consistent, reliable and traceable supply to our customers. Our stock shape production facilities are additionally certified to ISO 13485.

VESTAKEEP® PEEK resins and stock shapes for medical applications are thoroughly tested for biocompatibility and toxicity. For our implant grades, masterfiles are filed with the FDA. We provide full support to our customers with the registration of their devices.

Biocompatibility tests

All model specifications and series of EVONIK.

赢创 VESTAKEEP® PEEK —— 用于医疗应用的高性能聚醚醚酮材料 作为高性能聚合物的技术领导者，我们为医疗行业提供聚醚醚酮模塑材料。我们的 VESTAKEEP® 级别产品用于植入物、牙科应用和医疗设备，因其卓越的生物相容性和生物稳定性而改变了医疗技术应用的标准。 VESTAKEEP® PEEK —— 具有强大特性的新一代医疗材料 聚醚醚酮已在医疗植入应用中使用多年。VESTAKEEP® PEEK 是满足这些医疗应用未被满足需求的最新产品线。

VESTAKEEP® PEEK 的主要特性

• 卓越的生物相容性
• 抵抗所有常用灭菌方法
• 高伽马辐射抗性
• 卓越的疲劳性能
• 独特的延展性特性
• 机械性能接近皮质骨
• 高化学抗性
• 高抗消毒和清洁剂能力
• 非常好的耐磨性
• 高尺寸稳定性
• 卓越的生物稳定性
• 高抗蠕变能力
• 良好的电绝缘性能
• 良好的热绝缘性能

适用于多种医疗应用领域的高性能 由于其令人印象深刻的特性，VESTAKEEP® PEEK 生物材料可用于多种不同的医疗应用领域，如：

• 牙科护理
• 骨科
• 颅颌面（CMF）
• 医疗设备

四种 VESTAKEEP® PEEK 级别，为医疗植入物、牙科应用和医疗设备提供最佳性能 我们提供适用于长期可植入医疗设备（植入级）、永久接触黏膜（牙科级）以及短时间（最长 30 天）接触人血液、组织或骨骼（护理级）的 PEEK 解决方案。

• VESTAKEEP® Implant 长期 —— 特别为长期可植入医疗设备设计
• VESTAKEEP® Fusion 我们的 PEEK 解决方案添加了双相磷酸钙（BCP）作为功能性添加剂，具有促进骨传导的特性，可加速骨骼愈合
• VESTAKEEP® Dental 永久黏膜接触 —— 特别为可拆卸和固定假牙、牙冠和牙桥设计
• VESTAKEEP® Care 短时间接触人血液、组织或骨骼，最长 30 天 —— 特别为医疗设备设计

注塑成型 在赢创，我们用于制造医疗设备产品的一项关键技术是注塑成型。注塑成型是一种涉及将塑料颗粒熔化并在高压下将其注入模具型腔的过程。模具型腔的形状与所需产品的形状一致，塑料在冷却过程中固化。注塑成型使我们能够以最小的浪费和高效率生产复杂且精确的形状。 赢创提供一系列专门设计用于生产高质量注塑成型医疗设备部件的生物材料，适用于临时和永久性接触人体。 我们的 VESTAMID® 化合物专为精密注塑成型而定制，能够制造从微型部件到高度填充的配件等各种复杂部件。这些化合物可以在标准注塑成型机上进行加工，证实了它们在商业生产环境中的多功能性和易用性。 对于要求最高性能水平的应用，我们的 VESTAKEEP® PEEK 聚合物和化合物是首选材料。它们主要用于注塑成型和挤出成型的颗粒形式加工，还有粉末级别可用于涂层、激光烧结和压缩成型等特殊应用。我们最先进的测试中心配备了完善的设备，以确保 VESTAKEEP® 符合医疗行业的严格要求。 TROGAMID® Care 以其卓越的耐热性而闻名，提供了广泛的加工窗口。这种材料适用于注塑成型和挤出成型，我们的专家团队随时准备利用我们在广泛的测试和开发工作中积累的知识为您提供支持。 此外，我们的 RESOMER® 生物可吸收聚合物系列展示了我们在注塑成型加工条件方面的先进专业知识。RESOMER® 被设计为可以使用标准注塑成型技术轻松加工，使其成为制造具有精确机械性能的生物可吸收医疗设备的理想选择。

挤出成型 挤出成型是一种通过在高压和高温下将材料通过模具或喷嘴的方法来成型材料。挤出成型可以生产出各种形状和尺寸的产品，如管材、棒材、线材、薄膜、片材和型材。 赢创在挤出成型方面的专业知识通过我们的 VESTAMID®、VESTAKEEP®、TROGAMID® Care 和 RESOMER® 产品系列得到了充分体现，这些产品旨在满足医疗设备制造的严格要求。 VESTAMID® 化合物的设计注重多功能性，能够生产出高质量的型材、管材，包括多层管材以及其他复杂的挤出形状。这些材料针对传统三段式螺杆进行了优化，最小长度为 24D，确保了平稳的加工和顶级的产品成果。此外，还可以采用如屏障螺杆等替代螺杆设计来满足特殊的挤出要求，进一步展示了我们在工艺技术上的适应性。 对于要求最严格的医疗应用，我们的 VESTAKEEP® PEEK 聚合物和化合物以其卓越的性能脱颖而出。这些 PEEK 材料适用于注塑成型和挤出成型，主要以颗粒形式加工，还有粉末级别可用于涂层、激光烧结和压缩成型。我们先进的测试中心配备了完善的设备，能够处理所有常见工艺，确保 VESTAKEEP® 达到医疗技术的最高标准。 TROGAMID® Care 是赢创卓越生物材料的另一个例子，它提供了出色的加工灵活性和耐热性，使其非常适合注塑成型和挤出成型应用。此外，我们的 RESOMER® 产品组合以其先进的加工能力而闻名，可以轻松适应标准挤出成型技术。它允许制造出具有精确机械性能的生物可吸收医疗设备，以满足各种医疗应用的具体需求。对于 RESOMER®，我们提供标准和定制的丝材。 我们的定制丝材是根据您的确切规格精心定制的，从广泛的 RESOMER® 产品组合中挑选，以满足您对性能和功能的要求。此外，我们还专门制造定制的部件，包括板材、带材和棒材，这些部件都可以无缝集成到您的医疗设备或应用中。 赢创的全面加工服务，包括材料选择、准备和设备设置，旨在支持您的医疗设备的开发和优化。无论您需要用于医疗纺织品的单丝还是复杂的挤出部件，我们都可以从概念到商业化为您提供帮助。

VESTAKEEP® PEEK 质量和批准 赢创建立了一个基于医疗行业特定质量、工艺和性能要求的产品组合。 我们基于 ISO 9001:2008 的质量体系确保了向客户的供应是一致的、可靠的和可追溯的。我们的库存形状生产设施还获得了 ISO 13485 认证。 用于医疗应用的 VESTAKEEP® PEEK 树脂和库存形状都经过了生物相容性和毒性的彻底测试。对于我们的植入级产品，已向 FDA 提交了主文件。我们为客户提供全面的支持，以注册他们的设备。 生物相容性测试

赢创工业集团（Evonik Industries AG） 聚醚醚酮（PEEK）

• VESTAKEEP® 1000 G
• VESTAKEEP® 2000G
• VESTAKEEP® 4000 GF30
• VESTAKEEP® 4000 CF30
• VESTAKEEP® 2000 CF30
• VESTAKEEP® 2000 GF30
• VESTAKEEP® 4000 CC20
• VESTAKEEP® 5000G
• VESTAKEEP® L4000G
• VESTAKEEP® 1000P
• VESTAKEEP® 2000FP
• VESTAKEEP® 2000P
• VESTAKEEP® 2000 UFP20
• VESTAKEEP® 3300G
• VESTAKEEP® 4000FP
• VESTAKEEP® 4000P
• VESTAKEEP® i4 R
• VESTAKEEP® Care M20G
• VESTAKEEP® Care M40G
• VESTAKEEP® Care M33G-HP
• VESTAKEEP® Care M40R
• VESTAKEEP® D4 G
• VESTAKEEP® D4 R
• VESTAKEEP® DC4420 G
• VESTAKEEP® DC4420 R
• VESTAKEEP® DC4430 G
• VESTAKEEP® DC4430 R
• VESTAKEEP® DC4450 G
• VESTAKEEP® DC4450 R
• VESTAKEEP® DC4470 G
• VESTAKEEP® DC4470 R
• VESTAKEEP® i2 G
• VESTAKEEP® i4 G
• VESTAKEEP® i4 PL
• VESTAKEEP® i5 G
• VESTAKEEP® i5 R
• INFINAM® PEEK 9359 F
• VESTAKEEP® 2000G BK
• VESTAKEEP® 2000 UFP10
• VESTAKEEP® 2500 G High Purity
• VESTAKEEP® 3300 G High Purity
• VESTAKEEP® 4000 CF20
• VESTAKEEP® 4000 CFL30
• VESTAKEEP® 4000 G BK
• VESTAKEEP® 4000 GF30 BK
• VESTAKEEP® 5000 FP
• VESTAKEEP® 5000 P
• VESTAKEEP® 50001XT BK
• VESTAKEEP® Care M20 G black
• VESTAKEEP® Care M40 3DF
• VESTAKEEP® Easy Slide 1
• VESTAKEEP® i2 P
• VESTAKEEP® i2 UFP10
• VESTAKEEP® i4 3DF
• VESTAKEEP® i4 3DF-T
• VESTAKEEP® i4 P
• VESTAKEEP® iC 4506 G
• VESTAKEEP® iC 4506 R
• VESTAKEEP® iC 4520 G
• VESTAKEEP® iC 4520 R
• VESTAKEEP® iC4800 G
• VESTAKEEP® iC 4800 R
• VESTAKEEP® iC 4800 3DF
• VESTAKEEP® DC4462 G
• VESTAKEEP® DC4460 R
• VESTAKEEP® DC4460 G
• VESTAKEEP® 5000 CF30
• VESTAKEEP® 4500 G
• VESTAKEEP® 1000 CF30