# K161173: Avenue® T TLIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA, Inc.
- Decided: Sep 28, 2016 after 155 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 19 generations back to K841189 (1984). 167 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 171 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142645: Avenue T TLIF Cage, Ldr Spine USA, Inc. (2015) Summary page 4.
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System, Ldr Spine USA (2016) Summary page 4.

## Most influential descendants
- K172419: Velofix™ TLIF Cage (2017), 2 descendants of its own
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- K183243: Velofix TLIF Cage (2019), 0 descendants of its own

## Indications for use
The Avenue T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K161173
Methodology: https://510kreport.com/methodology