# K180153: X-spine Cortical Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Mar 15, 2018 after 55 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: 16 generations back to K040583 (2004). 213 ancestors in all.
No later device cites it as a predicate yet.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152132: X-spine Pedicle Screw System, X-Spine Systems, Inc. (2015) Summary page 5.
- K152968: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2015) Summary page 5.
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 5.

## Indications for use
The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications: * Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies * Severe spondylolisthesis (Grades 3 and 4) of the L.5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion * Spondylolisthesis * Trauma (i.e. fracture or dislocation) = Spinal stenosis » Deformities or curvatures (i.e. scoliosis, kyphosis) » Spinal tumor » Pseudoarthrosis, and/or * Failed previous fusion

Source page: https://510kreport.com/device/K180153
Methodology: https://510kreport.com/methodology