# K161821: Stryker Universal Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Dec 8, 2016 after 160 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: 4 generations back to K954385 (1996). 11 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 4.

## Most influential descendants
- K182425: Universal Mesh - Sterile (2018), 0 descendants of its own
- K170725: Stryker Universal Mesh (2017), 0 descendants of its own

## 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/K161821
Methodology: https://510kreport.com/methodology