# K112557: Stryker Universal Neuro 3 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jan 5, 2012 after 125 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: 6 generations back to K761228 (1976). 29 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031659: Universal Neuro System, Stryker Instruments (2003) Summary page 3.
- K983528: Micro Dynamic Mesh, Howmedica Corp. (1998) Summary page 3.
- K022012: Synthes Low Profile Neuro System, Synthes (Usa) (2002) Summary page 3.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 3.
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 3.

## Most influential descendants
- K120352: Stryker Quikflap Sterile Procedure Pack (2012), 4 descendants of its own
- K151387: Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (2015), 2 descendants of its own
- K140309: Cranioplug (2014), 2 descendants of its own
- K181539: OSSDSIGN Cranioplug (2018), 1 descendant of its own
- K171152: Stryker Universal Neuro III System AXS Screw (2017), 1 descendant of its own

## 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/K112557
Methodology: https://510kreport.com/methodology