# K180301: AXIS 5.5 Lumbar Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Axis Orthopaedics
- Decided: Apr 10, 2018 after 67 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: 3 generations back to K011508 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042167: Modification to: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 5.

## Indications for use
The AXIS 5.5 LUMBAR PEDICLE SCREW SYSTEM is intended for posterior, non-cervical fixation of 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; pseudarthrosis; and/or failed previous fusion.

Source page: https://510kreport.com/device/K180301
Methodology: https://510kreport.com/methodology