# K080075: Modification to: Vertefix Pedicle Screw Spinal System

- Pathway: 510(k) (Special)
- Applicant: Elite Surgical Supplies (Pty), Ltd.
- Decided: Jan 28, 2008 after 17 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 2 generations back to K051971 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063453: Vertefix Pedicle Screw Spinal System, Elite Surgical Supplies (Pty), Ltd. (2007) Summary page 3.

## Indications for use
The Vertefix® Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine, for the following indications: * Spondylolisthesis; * Trauma (e.g. fracture or dislocation); * Spinal stenosis; * Deformities or curvatures (scoliosis, kyphosis and lordosis); * Tumor; * Pseudoarthrosis; and * Failed previous fusion.

Source page: https://510kreport.com/device/K080075
Methodology: https://510kreport.com/methodology