# K231737: ANAX™ 5.5 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Innosys Co., Ltd.
- Decided: Oct 26, 2023 after 134 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 K000319 (2000). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 4.
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 4.
- K100765: Fixpine II System, Dio Medical Co., Ltd. (2010) Summary page 4.

## Most influential descendants
- K233960: INNOVERSE Spinal System (2024), 0 descendants of its own

## Indications for use
The ANAX™ 5.5 SPINAL SYSTEM is a posterior, non cervical 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: • Spondylolisthesis (Grade 3 and 4) • 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/K231737
Methodology: https://510kreport.com/methodology