# K031659: Universal Neuro System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Sep 10, 2003 after 105 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K761228 (1976). 26 ancestors in all.
12 later devices descend from it; 3 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)
- K022185: Universal CMF System, Stryker Instruments (2002)
- K924138: Osteomed M3 System (SBF System), Osteomed Corp. (1993) Summary page 1.
- K023260: 1.2MM Osteomed Auto-Drive Screw System, Osteomed Corp. (2002)
- K022012: Synthes Low Profile Neuro System, Synthes (Usa) (2002)

## Most influential descendants
- K112557: Stryker Universal Neuro 3 System (2012), 9 descendants of its own
- 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

## Indications for use
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.

Source page: https://510kreport.com/device/K031659
Methodology: https://510kreport.com/methodology