3D Systems has received the US FDA 510(k) clearance of its VSP® PEEK Cranial Implant, a 3D-printed, patient-specific cranial implant solution that includes a complete FDA-cleared workflow comprising segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP® i4 3DF PEEK (polyetheretherketone), and a pre-defined production process.

The VSP PEEK Cranial Implant is the first FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull and can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining. The printer’s cleanroom-based architecture, combined with simplified post-processing workflows, makes it an ideal technology for producing patient-specific medical devices at the hospital site with faster turnaround times while keeping overall costs under control.

This solution has already enabled nearly 40 successful cranioplasties in Switzerland at the University Hospital of Basel, in Austria at the University Hospital of Salzburg, and in Israel at the Tel-Aviv Sourasky Medical Center. We are now looking to the next applications for VSP PEEK Cranial Implant, which includes 3D-printed spine interbody fusion implants, carbon fiber-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications,” said Dr. Gautam Gupta, SVP & General Manager of Medical Devices at 3D Systems.

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