A cleared PEEK cranial implant workflow links planning to production
3D Systems announced FDA 510(k) clearance for its patient-specific VSP PEEK Cranial Implant solution.
What happened
3D Systems announced the clearance in April 2024. The solution addressed patient-specific cranial reconstruction using printed PEEK, an implant material already familiar in medical manufacturing.
The company described an integrated workflow combining segmentation and modeling software, the EXT 220 MED printer, specified Evonik PEEK material and a defined production process. The FDA database records the clearance decision on April 4, 2024.
The clearance applied to the named device and workflow. It did not establish blanket clearance for any PEEK print, printer or surgical application. This archive brief reports the regulatory milestone rather than offering clinical guidance.
Read the sources
Primary-source reporting; this is not a hands-on review. Sources checked Oct 24, 2026.