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.

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.

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.

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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.