# K183243: Velofix TLIF Cage

- Pathway: 510(k) (Special)
- Applicant: U&I Corporation
- Decided: Jul 10, 2019 after 231 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K841189 (1984). 287 ancestors in all.
No later device cites it as a predicate yet.
1 of 288 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172419: Velofix™ TLIF Cage, U&I Corporation (2017) Summary page 4.
- K181829: Velofix TLIF Cage, U&I Corporation (2018) Summary page 4.
- K140864: Veloxtm Interbody Fusion System, U&I Corp. (2014) Summary page 4.

## Indications for use
The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

Source page: https://510kreport.com/device/K183243
Methodology: https://510kreport.com/methodology