# K132738: Cogent Med-Lif

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Spine, LLC
- Decided: Apr 15, 2014 after 224 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: 15 generations back to K841189 (1984). 91 ancestors in all.
13 later devices descend from it; 2 cite 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)
- K113478: Plif Cage, Eisertech, LLC (2012) Summary page 1.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 1.
- K090566: Pathway Avid, Custom Spine, Inc. (2009) Summary page 1.
- K121693: A-Wedge Anterior Interbody System (a-Wedge Ais), Sapphire Medical Group, Inc. (2012) Summary page 1.

## Most influential descendants
- K142193: Cogent Med-Lif XL (2014), 12 descendants of its own
- K151406: Cogent Lateral Interbody System (2016), 11 descendants of its own
- 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

## Indications for use
The Cogent Med-LIE is indicated for use with autogenous; bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from I2 to Si1. These DDID 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 rnths 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/K132738
Methodology: https://510kreport.com/methodology