# K152076: PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Aug 26, 2015 after 30 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: 5 generations back to K904111 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121153: Peek Customized Craial Implant Kit, Stryker (2012) Summary page 5.

## Indications for use
The Stryker PEEK Customized Cranial Implant Kit is intended to be used to replace bony voids in the cranial and the craniofacial skeleton. The Stryker PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the cranial and craniofacial skeleton in patients 12 years of age and older.

Source page: https://510kreport.com/device/K152076
Methodology: https://510kreport.com/methodology