# K102334: TRANS1 Axialif Plus

- Pathway: 510(k) (Traditional)
- Applicant: Trans1 Incorporated
- Decided: Mar 14, 2011 after 209 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: 4 generations back to K002371 (2000). 6 ancestors in all.
61 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073514: TRANS1 Axial Fixaton System, Trans1 Incorporated (2008) Summary page 1.
- K092124: Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif II, Trans1 Incorporated (2010) Summary page 1.

## Most influential descendants
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K214006: Invictus® Spinal Fixation System (2022), 16 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own

## Indications for use
TranS I AxiaLIFO Plus System is intended to provide anterior stabilization of the L5-S I or L4-S I 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 I or 2 if single-level; Grade I 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 L_4-SI in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLiF.

Source page: https://510kreport.com/device/K102334
Methodology: https://510kreport.com/methodology