# K201457: Auxein Brand Vertaux 5.5 mm Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited/71164
- Decided: Apr 6, 2021 after 309 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: 8 generations back to K040583 (2004). 41 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091442: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 5.

## Most influential descendants
- K243281: LOCK-IN Spinal Fixation System (2024), 0 descendants of its own
- K240233: Pitkar Spinal Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: *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 and pseudarthrosis

Source page: https://510kreport.com/device/K201457
Methodology: https://510kreport.com/methodology