# K172419: Velofix™ TLIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Dec 4, 2017 after 116 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: 20 generations back to K841189 (1984). 228 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 231 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132926: Velofixtm Interbody Fusion System, U&I Corp. (2014) Summary page 4.
- K140864: Veloxtm Interbody Fusion System, U&I Corp. (2014) Summary page 4.
- K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 4.
- K100743: Atlas Spine Pivoting System, Atlas Spine, Inc. (2010) Summary page 4.
- K151726: AVS AL and AVS ALign PEEK Spacers, AVS PL  and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer, Stryker Corporation (2016) Summary page 4.
- K122518: Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage Talon Tifa Cage, Bm Korea Co., Ltd. (2013) Summary page 4.
- K161173: Avenue® T TLIF Cage, Ldr Spine USA, Inc. (2016) Summary page 4.
- K162220: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage, Dio Medical Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- K183243: Velofix TLIF Cage (2019), 0 descendants of its own

## 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 S1 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/K172419
Methodology: https://510kreport.com/methodology