# K192792: TranS1 AxiaLIF Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Trans1
- Decided: Nov 20, 2019 after 51 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K002371 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102334: TRANS1 Axialif Plus, Trans1 Incorporated (2011) Summary page 4.

## Indications for use
TranS1 AxiaLIF Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. The AxiaLIF Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF.

Source page: https://510kreport.com/device/K192792
Methodology: https://510kreport.com/methodology