3D Systems VSP PEEK Cranial Implant System — FDA Cleared

3D SystemsMedical/Dentalsince 2024

3D Systems VSP PEEK Cranial Implant System — FDA Cleared

Patient-specific PEEK cranial implants for cranioplasty

Medical/Dental85% confidence

MEDICAL/DENTAL · PART PHOTO

Challenge

Conventional cranial implants use titanium mesh or PMMA — neither is ideal. PEEK is radiolucent (MRI-compatible) and biomechanically closer to bone, but had not been FDA-cleared in additively manufactured form.

Solution

3D Systems received FDA 510(k) clearance in April 2024 for the VSP PEEK Cranial system — the world's first FDA-cleared additively manufactured PEEK implant. Printed on the EXT 220 MED printer using Evonik's medical-grade PEEK filament.

Outcomes

01Successful AM implementation

Technologies

Fused Deposition Modeling

Source

60+ successful cranioplasties worldwide by end of 2024; European and Israeli clinical use

Cite this page

APA

AM Roadmap. (2024). 3D Systems VSP PEEK Cranial Implant System — FDA Cleared. AM Roadmap (v0.4.2-fixes-deployed). Retrieved 2026-05-17, from https://amroadmap.com/success-stories/3dsystems-vsp-peek-cranial-2024

BibTeX

@misc{amroadmap_3d_systems_vsp_peek_cranial_implant_syst_2024,
  title  = {3D Systems VSP PEEK Cranial Implant System — FDA Cleared},
  author = {{AM Roadmap}},
  year   = {2024},
  url    = {https://amroadmap.com/success-stories/3dsystems-vsp-peek-cranial-2024},
  note   = {AM Roadmap dataset v0.4.2-fixes-deployed, accessed 2026-05-17}
}

Canonical URL: https://amroadmap.com/success-stories/3dsystems-vsp-peek-cranial-2024