# K222415: Rexious Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Medical Corporation
- Decided: Oct 25, 2022 after 76 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: 10 generations back to K990745 (1999). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173131: Rexious Spinal Fixation System, Huvexel Co., Ltd. (2017) Summary page 5.
- K113324: Rexious Hook Fixation Systems, Dio Medical Co., Ltd. (2012) Summary page 5.
- K100765: Fixpine II System, Dio Medical Co., Ltd. (2010) Summary page 5.
- K111362: Rexious Spinal Fixation System, Dio Medical Co., Ltd. (2011) Summary page 5.

## Most influential descendants
- K232586: Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System (2023), 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). The Rexious Spinal Fixation System is intended for use as a posterior. noncervical, non-pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration ofthe disc confired 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/K222415
Methodology: https://510kreport.com/methodology