# K232586: Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K&J Consulting Corp.
- Decided: Oct 24, 2023 after 60 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: 15 generations back to K853033 (1985). 224 ancestors in all.
No later device cites it as a predicate yet.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222415: Rexious Spinal Fixation System, Dio Medical Corporation (2022) Summary page 5.
- K133350: Revere Stabilization System, Globus Medical, Inc. (2014) Summary page 5.

## Indications for use
The Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are 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). When used for posterior non-cervical screw fixation in pediatric patients, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M_TM Spinal Fixation System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M_TM Spinal Fixation System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Source page: https://510kreport.com/device/K232586
Methodology: https://510kreport.com/methodology