# K182425: Universal Mesh - Sterile

- Pathway: 510(k) (Special)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Nov 6, 2018 after 61 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954385 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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 5.
- K170773: Stryker Universal Mesh, Stryker (2017) Summary page 5.

## Recalls of this device
- Mar 29, 2024 · Class II · Z-1785-2024: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

## 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). The Universal Mesh is indicated for non-load-bearing reconstruction in the maxillofacial skeleton of patients in whom skeletal growth is complete.

Source page: https://510kreport.com/device/K182425
Methodology: https://510kreport.com/methodology