# K233960: INNOVERSE Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Innosys Co., Ltd.
- Decided: Feb 6, 2024 after 53 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 K000319 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231737: ANAX™ 5.5 Spinal System, Innosys Co., Ltd. (2023) Summary page 4.
- K173524: ANAX 5.5™ Spinal System, U&I Corporation (2017) Summary page 4.
- K162189: ANAX™ 5.5 Spinal System, U&I Corporation (2016) Summary page 4.
- K143417: ANAX 5.5 Spinal System, U&I Corporation (2015) Summary page 4.
- K132101: Anax 5.5 Spinal System, U&I Corporation (2013) Summary page 4.

## Indications for use
The INNOVERSE Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: * Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra * Degenerative spondylolisthesis with objective evidence of neurological impairment * Trauma (i.e., fracture or dislocation) * Spinal stenosis * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K233960
Methodology: https://510kreport.com/methodology