# K050965: TRANS1 Axialif System

- Pathway: 510(k) (Traditional)
- Applicant: Trans1 Incorporated
- Decided: Jun 14, 2005 after 57 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: 2 generations back to K002371 (2000). 2 ancestors in all.
63 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040426: TRANS1 Axial Fixation System, Trans1, Inc. (2004) Summary page 1.

## Most influential descendants
- K073514: TRANS1 Axial Fixaton System (2008), 62 descendants of its own
- K102334: TRANS1 Axialif Plus (2011), 61 descendants of its own
- 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

## Indications for use
The TranSI® AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade I or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranSI® AxiaLIFTM is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - SI in conjunction with legally marketed facet and pedicle screw systems.

Source page: https://510kreport.com/device/K050965
Methodology: https://510kreport.com/methodology