# K243004: Xpine Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Nov 8, 2024 after 43 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: 17 generations back to K040583 (2004). 171 ancestors in all.
No later device cites it as a predicate yet.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142381: Xia 3 Spinal System, Stryker Corp. (2014) Summary page 5.

## Indications for use
Xpine Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • degenerative disc disease (DDD; 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 • pseudoarthrosis • failed previous fusion

Source page: https://510kreport.com/device/K243004
Methodology: https://510kreport.com/methodology