# K170725: Stryker Universal Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Nov 13, 2017 after 249 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 K954385 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161821: Stryker Universal Mesh, Stryker (2016) Summary page 4.

## Indications for use
The Universal Mesh is indicated for reconstruction, stabilization and/or rigid fixation subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).

Source page: https://510kreport.com/device/K170725
Methodology: https://510kreport.com/methodology