# K260362: QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)

- Pathway: 510(k) (Traditional)
- Applicant: MANTIZ Co., Ltd.
- Decided: Jul 24, 2026 after 170 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: 11 generations back to K990745 (1999). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210420: Goblin and Goblin LS Pedicle Screw Systems, Medynus, Inc. (2021) Summary page 5.

## Indications for use
The QUATTRO Spinal System are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: * Degenerative disc disease (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 and pseudarthrosis

Source page: https://510kreport.com/device/K260362
Methodology: https://510kreport.com/methodology