# K190471: 4CIS® Chiron Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Jul 24, 2019 after 148 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: 1 generation back to K111136 (2012). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012) Summary page 4.

## Most influential descendants
- K222229: Advanced LumFix Spinal Fixation System (2023), 2 descendants of its own
- K203233: 4CIS Chiron Spinal Fixation System (2022), 1 descendant of its own
- K250582: COLONNADE Posterior Screw Fixation System (2025), 0 descendants of its own
- K231655: 4CIS® Chiron Spinal Fixation System (2024), 0 descendants of its own
- K240233: Pitkar Spinal Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
The 4CIS® Chiron 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K190471
Methodology: https://510kreport.com/methodology