# K180324: Patriot Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Valorus Spine
- Decided: Apr 6, 2018 after 60 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). 182 ancestors in all.
No later device cites it as a predicate yet.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 5.
- K161363: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2016) Summary page 5.
- K101278: Inertia Pedicle Screw System, Nexxt Spine, LLC (2010) Summary page 5.

## Indications for use
The Patriot Spinal Fixation System, when used in the non-cervical posterior spine (T1 to S1), 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudoarthrosis, and failed previous fusion. In addition, when used placed between L5 and S1, the Patriot Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft.

Source page: https://510kreport.com/device/K180324
Methodology: https://510kreport.com/methodology