# K151406: Cogent Lateral Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Spine, LLC
- Decided: Feb 25, 2016 after 275 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: 17 generations back to K841189 (1984). 93 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132738: Cogent Med-Lif, Cogent Spine, LLC (2014) Summary page 4.
- K142193: Cogent Med-Lif XL, Cogent Spine, LLC (2014) Summary page 4.

## Most influential descendants
- K161404: Genesys Spine Apache® Lateral Lumbar Interbody Fusion System (2016), 10 descendants of its own
- K182987: Genesys Spine 3DP Lumbar Interbody System (2019), 9 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K211417: F3D-C2 Cervical Stand-Alone System (2022), 3 descendants of its own
- K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System (2023), 2 descendants of its own

## Indications for use
The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K151406
Methodology: https://510kreport.com/methodology