# K173131: Rexious Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Huvexel Co., Ltd.
- Decided: Dec 8, 2017 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: 9 generations back to K990745 (1999). 48 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111362: Rexious Spinal Fixation System, Dio Medical Co., Ltd. (2011) Summary page 5.
- K100788: Cocr Rods, Globus Medical, Inc. (2010) Summary page 5.

## Most influential descendants
- K222415: Rexious Spinal Fixation System (2022), 1 descendant 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
- K232586: Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System (2023), 0 descendants of its own
- K220285: PINE Pedicle Screw System (2022), 0 descendants of its own

## Indications for use
The Rexious 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K173131
Methodology: https://510kreport.com/methodology