# K151387: Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Jun 24, 2015 after 29 days
- Product code: HBW (Fastener, Plate, Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K761228 (1976). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 33 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 5.

## Most influential descendants
- K171152: Stryker Universal Neuro III System AXS Screw (2017), 1 descendant of its own
- K231208: Stryker Resorbable Fixation System (2023), 0 descendants of its own

## Indications for use
The Stryker Universal Neuro III 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/K151387
Methodology: https://510kreport.com/methodology