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Materials & Solutions
Regulatory support

Regulatory Support

Working with you to help you through the journey to clearance and beyond

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Regulatory support
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Overview

Your long-standing, trusted partner in high performance polymers

ZERO
fast fact

Zero material-related recalls

PEEK-OPTIMATM polymers have gained the trust of healthcare professionals, patients and OEMs with zero material related-recalls 

20+
fast fact
Decades of proven clinical history
Over 20 years ago, the biocompatible PEEK-OPTIMATM Natural polymer became the material of choice in interbody fusion with a successful clinical track record
15M
fast fact
Millions of devices implanted worldwide
Today, approximately 15 million PEEK-OPTIMATM devices are implanted worldwide

Helping you on your journey to commercialization

European Union Medical Device Regulation (MDR)

Compliance with PEEK-OPTIMA™ polymer implantable devices - what does it mean for you?

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Launching a PEEK-OPTIMATM HA Enhanced device, and already have a product in the market?


The FDA Special 510(k) Program is intended to facilitate the submission, review, and clearance of a change to a manufacturer’s own legally marketed predicate device (“existing device”) that is already authorized for commercial distribution through 510(k) clearance. 
Ask us about the Special 510(k) Program
Victrex Map

Expand your PEEK portfolio globally 

We’ll help you enter and evaluate new markets in the US, Europe and Asia. Our team of global regulatory affairs experts can support you to navigate regulatory pathways, provide you with supporting documents & facilitate workshops between you and authorities including the FDA and the China's National Medical Products Administration (NMPA).

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SHAPING FUTURE PERFORMANCETM

From the invention of PEEK over 40 years ago, Victrex has continually pioneered new PAEK-based polymers, materials and solutions that have transformed markets, delivering global impact in the toughest environments.

We bring transformational & sustainable solutions that address world material challenges every day.

Certifications
ukas logo ISO 13485 Certified
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