# K231655: 4CIS® Chiron Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Nov 26, 2024 after 539 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: 12 generations back to K841189 (1984). 80 ancestors in all.
No later device cites it as a predicate yet.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203233: 4CIS Chiron Spinal Fixation System, Solco Biomedical Co., Ltd. (2022) Summary page 6.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012) Summary page 6.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 6.
- K012871: Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177, Interpore Cross Intl. (2001) Summary page 6.
- K123134: Easyspine System, Ldr Spine USA, Inc. (2013) Summary page 6.

## 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/K231655
Methodology: https://510kreport.com/methodology