# K132101: Anax 5.5 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Nov 25, 2013 after 140 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 5 generations back to K000319 (2000). 12 ancestors in all.
13 later devices descend from it; 7 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 2.
- K100765: Fixpine II System, Dio Medical Co., Ltd. (2010) Summary page 1.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Most influential descendants
- K160731: LumFix Spinal Fixation Sytem (2016), 6 descendants of its own
- K143417: ANAX 5.5 Spinal System (2015), 4 descendants of its own
- K162189: ANAX™ 5.5 Spinal System (2016), 3 descendants of its own
- K222229: Advanced LumFix Spinal Fixation System (2023), 2 descendants of its own
- K173524: ANAX 5.5™ Spinal System (2017), 2 descendants of its own

## Indications for use
The ANAXTM 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 autogerious 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 (iLe., scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K132101
Methodology: https://510kreport.com/methodology