The VSP PEEK Cranial Implant for cranioplasty procedures to restore skull defects. Credit: 3D Systems.

3D Systems has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VSP PEEK Cranial Implant.

The patient-specific implant includes the EXT 220 MED 3D printer and represents a significant advancement in cranial reconstruction technology.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

It is said to be the world’s first FDA-cleared, 3D-printed additively manufactured PEEK implant designed for cranioplasty procedures to restore skull defects.

3D Systems said the solution has already been successfully implemented in nearly 40 cranioplasties across Europe.

The VSP PEEK Cranial Implant system also includes the segmentation and 3D modelling software, Evonik VESTAKEEP i4 3DF PEEK, and a pre-defined production process.

See Also:

This technology uses additive manufacturing solutions to produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining. This helps in reducing costs and waste.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The cleanroom environment of the EXT 220 MED printer further enhances the production process, making it suitable for hospital site manufacturing.

3D Systems medical devices senior vice-president and general manager Dr Gautam Gupta said: “Receiving FDA clearance for our VSP PEEK Cranial Implant solution is a significant milestone in our journey.

“Our EXT 220 MED printing system has already enabled the production of nearly 40 cranial implants in support of successful cranioplasties throughout Europe. With this FDA clearance, we are now able to bring VSP PEEK Cranial Implant to the US — setting a new standard of excellence for these procedures.

“We are now looking to the next applications for this technology, which includes 3D-printed spine interbody fusion implants, carbon fibre-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.”

Last year, 3D Systems partnered with Klarity to expand the distribution of its VSPBolus solution.