# K181824: CBT Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Dec 13, 2018 after 157 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: 6 generations back to K000319 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132101: Anax 5.5 Spinal System, U&I Corporation (2013) Summary page 4.

## Indications for use
The CBT Screw Fixation System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: - Spondylolisthesis - Degenerative spondylolisthesis with objective evidence of neurological impairment - Trauma (i.e., fracture or dislocation) - Spinal stenosis - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion

Source page: https://510kreport.com/device/K181824
Methodology: https://510kreport.com/methodology