# K110588: Leucadia Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Phygen, LLC
- Decided: May 25, 2011 after 84 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113366: Leucadia Autolok Pedicle Screw System (2012), 1 descendant of its own
- K182339: LEUCADIA AUTOLOK™ Pedicle Screw System (2018), 0 descendants of its own
- K120355: Leucadia 4.5 MM Pedicle Screw System (2012), 0 descendants of its own
- K112931: Leucadia (TM) Mis Pedicle Screw System (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K110588
Methodology: https://510kreport.com/methodology