# K113348: Cougar System

- Pathway: 510(k) (Special)
- Applicant: Johnson & Johnson
- Decided: Dec 13, 2011 after 29 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). 27 ancestors in all.
591 later devices descend from it; 3 cite it directly.
1 of 619 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 1.
- K080568: X-Mesh Expandable Cage System, Depuy Spine, Inc. (2008) Summary page 1.
- K031635: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 1.
- K110454: Cougar LS Lateral Cage System, Johnson & Johnson (2011) Summary page 1.
- K101923: Concorde Curve System, Depuy Spine (2010) Summary page 1.

## Most influential descendants
- K140319: Coroent TI-C System (2014), 590 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own

## Indications for use
The COUGAR System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation. The COUGAR System is indicated for use in the thoracolumbar spine (i.e., T1-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. The COUGAR System is also indicated for treating fractures of the thoracic and lumbar spine. The COUGAR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, the COUGAR System is intended for use with DePuy Spine supplemental internal fixation.

Source page: https://510kreport.com/device/K113348
Methodology: https://510kreport.com/methodology