# K203233: 4CIS Chiron Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Jun 1, 2022 after 576 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: 2 generations back to K111136 (2012). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190471: 4CIS® Chiron Spinal Fixation System, Solco Biomedical Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K231655: 4CIS® Chiron Spinal Fixation 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: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 5. Tumor; 6. Stenosis; 7. Failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K203233
Methodology: https://510kreport.com/methodology