# K122896: Cougar LS 15 Lateral Cage System

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Oct 18, 2012 after 27 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: 11 generations back to K841189 (1984). 25 ancestors in all.
205 later devices descend from it; 2 cite it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082128: Depuy Spine Lateral Cage System, Depuy Spine (2008) Summary page 1.
- K110454: Cougar LS Lateral Cage System, Johnson & Johnson (2011) Summary page 1.

## Most influential descendants
- K140759: Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar LS Lateral (2014), 204 descendants of its own
- K151773: CONCORDE Bullet Lumbar Interbody System (2015), 201 descendants of its own
- K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (2016), 127 descendants of its own
- K162327: COUGAR® LS Lateral Cage System and COUGAR® System (2016), 111 descendants of its own
- K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System  with TiONIC Technology (2017), 109 descendants of its own

## Indications for use
The CougarO LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., Ti to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomnechanical integrity of th6 anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation. The CougarO LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to Si. These ODD patients may also have up to Grade 1 spondylolisthesis br retrolisthesis at the involved levels. ODD 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 implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

Source page: https://510kreport.com/device/K122896
Methodology: https://510kreport.com/methodology