# K063453: Vertefix Pedicle Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Elite Surgical Supplies (Pty), Ltd.
- Decided: Aug 30, 2007 after 288 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: 1 generation back to K051971 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051971: Optima Spinal System, U&I Corp. (2005)

## Cited in the summary but kept off the family tree
- K042655: Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456, Respironics New Jersey, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K003190: EN Bloc Biopsy System, Neothermia Corp. (2001). Our reading of the summary gave K003190, FDA’s number for EN Bloc Biopsy System (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “XIA Spine System Hooks”. Kept off the family tree.

## Most influential descendants
- K080075: Modification to: Vertefix Pedicle Screw Spinal System (2008), 0 descendants of its own

## 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/K063453
Methodology: https://510kreport.com/methodology