# K112931: Leucadia (TM) Mis Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Phygen, LLC
- Decided: Nov 2, 2011 after 30 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
Longest line of descent: 1 generation back to K110588 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110588: Leucadia Pedicle Screw System, Phygen, LLC (2011) Summary page 1.

## Indications for use
The LEUCADIA TM MIS Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.

Source page: https://510kreport.com/device/K112931
Methodology: https://510kreport.com/methodology