# K222229: Advanced LumFix Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: CG Bio Co., Ltd.
- Decided: May 25, 2023 after 304 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 K853033 (1985). 167 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 170 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160731: LumFix Spinal Fixation Sytem, CG Bio Co., Ltd. (2016) Summary page 5.
- K142835: Iliad Pedicle Screw System and Zenius Pedicle Screw System, Medyssey USA, Inc. (2015) Summary page 5.
- K190471: 4CIS® Chiron Spinal Fixation System, Solco Biomedical Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K250582: COLONNADE Posterior Screw Fixation System (2025), 0 descendants of its own
- K231443: Mini-OSTEO Pedicle Fixation System (2023), 0 descendants of its own

## Indications for use
The Advanced LumFix Spinal 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.

Source page: https://510kreport.com/device/K222229
Methodology: https://510kreport.com/methodology