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# FDA Clears 3D Printed Cranial Implant
- URL: https://www.fdaweb.com/fda-clears-3d-printed-cranial-implant/
- Published: 2024-04-15T12:00:00.000Z
- Updated: 2026-09-14T14:28:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156778

FDA has cleared a 3D Systems 510(k) for its 3D-printed, patient-specific cranial implant VSP PEEK Cranial Implant, which is intended for cranioplasty procedures to restore defects in the skull. The device includes a “complete FDA-cleared workflow comprising segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik [VESTAKEEP i4 3DF](https://medical.evonik.com/en/peek-biomaterial-implants/vestakeep-filament-3d-printing?ref=fdaweb.com) PEEK (polyetheretherketone), and a pre-defined production process,” according to the company. The system can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining, the company says.

“This implant-grade, high-performance polymer has a well-known clinical history in medical device applications due to its exceptional performance with mechanical properties closely mirroring human bone, 3D Systems says.