# K173524: ANAX 5.5™ Spinal System

- Pathway: 510(k) (Special)
- Applicant: U&I Corporation
- Decided: Dec 13, 2017 after 29 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K000319 (2000). 15 ancestors in all.
2 later devices descend from it; 2 cite 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)
- 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.

## Most influential descendants
- K231737: ANAX™ 5.5 Spinal System (2023), 1 descendant of its own
- K233960: INNOVERSE Spinal System (2024), 0 descendants of its own

## Recalls of this device
- May 26, 2020 · Class II · Z-2672-2020: 6.0x50mm poly-reduction screws were laser etched 6.0x45

## Indications for use
The ANAX™ 5.5 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: -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/K173524
Methodology: https://510kreport.com/methodology