# K131775: Universal Neuro 3 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Oct 17, 2013 after 122 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: 8 generations back to K761228 (1976). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112557: Stryker Universal Neuro 3 System, Stryker (2012) Summary page 2.
- K120352: Stryker Quikflap Sterile Procedure Pack, Stryker (2012)

## Indications for use
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Source page: https://510kreport.com/device/K131775
Methodology: https://510kreport.com/methodology