# K231834: VSP PEEK Cranial Implant

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems, Inc.
- Decided: Apr 4, 2024 after 287 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904111 (1990). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI), Kelyniam Global, Inc. (2019) Summary page 5.

## Indications for use
The VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cranial skeleton of patients 21 years of age and older.

Source page: https://510kreport.com/device/K231834
Methodology: https://510kreport.com/methodology