# K250582: COLONNADE Posterior Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: CG Bio Co., Ltd.
- Decided: May 8, 2025 after 70 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: 13 generations back to K853033 (1985). 168 ancestors in all.
No later device cites it as a predicate yet.
1 of 169 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222229: Advanced LumFix Spinal Fixation System, CG Bio Co., Ltd. (2023) Summary page 5.
- K160731: LumFix Spinal Fixation Sytem, CG Bio Co., Ltd. (2016) Summary page 5.

## Indications for use
The COLONNADE Posterior Screw Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Fenestrated screws are not intended for use with cement.

Source page: https://510kreport.com/device/K250582
Methodology: https://510kreport.com/methodology