# K101374: Aaxter A3 Posterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aaxter Co., Ltd.
- Decided: Mar 16, 2011 after 303 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: 3 generations back to K884263 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031595: U & I America Spinal Hook System, U&I Corp., America (2003) Summary page 2.

## Indications for use
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication; spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. In addition, the Aaxter A3 Posterior Spinal System is 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 spondylolisthesis with objective evidence of neurological impairment * Fracture of the vertebral body * Dislocation - Scoliosis * Kyphosis "Spinal tumnor

Source page: https://510kreport.com/device/K101374
Methodology: https://510kreport.com/methodology