# K190229: Stryker PEEK Customized Cranial Implant Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jul 11, 2019 after 156 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: 6 generations back to K904111 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153248: PEEK Customized Cranial Implant, Stryker (2016) Summary page 4.

## Most influential descendants
- K203055: Stryker PEEK Customized Cranial Implant Kit (2021), 0 descendants of its own

## Indications for use
The PEEK Customized Cranial Implant Kit is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.

Source page: https://510kreport.com/device/K190229
Methodology: https://510kreport.com/methodology