# K160731: LumFix Spinal Fixation Sytem

- Pathway: 510(k) (Traditional)
- Applicant: CG Bio Co., Ltd.
- Decided: Oct 4, 2016 after 201 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 6 generations back to K000319 (2000). 20 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093104: Medyssey CO., LTD., Zenius Spinal System, Medyssey Co, Ltd. (2010) Summary page 5.
- K132101: Anax 5.5 Spinal System, U&I Corporation (2013) Summary page 5.

## Most influential descendants
- K222229: Advanced LumFix Spinal Fixation System (2023), 2 descendants of its own
- K210420: Goblin and Goblin LS Pedicle Screw Systems (2021), 1 descendant of its own
- K260362: QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (2026), 0 descendants of its own
- 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 LumFix Spinal Fixation System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K160731
Methodology: https://510kreport.com/methodology