# K122814: Galleon Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Everest Spine, LLC
- Decided: Dec 3, 2012 after 81 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 5 generations back to K944736 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091110: Spinal Edge Titan Pedicle Screw System, Spinal Edge, LLC (2009) Summary page 1.

## Indications for use
The Everest Spine Galleon Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-SI vertebrae;,trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to ifusion with bone graft. The levels of fixation are T8- SI.

Source page: https://510kreport.com/device/K122814
Methodology: https://510kreport.com/methodology