# K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: May 22, 2009 after 323 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: 8 generations back to K841189 (1984). 16 ancestors in all.
1,008 later devices descend from it; 36 cite it directly.
1 of 1,025 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K023835: Devex Mesh System, Depuyacromed (2003) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K073320: Cimplicity Spinal System, Spine Smith Partners L.P. (2008) Summary page 1.
- K031635: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 1.
- K030833: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 1.
- K041722: Modification to VBR Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K052746: Concorde VBR Spinal System, Depuy Spine, Inc. (2005) Summary page 1.

## Most influential descendants
- K101923: Concorde Curve System (2010), 609 descendants of its own
- K110454: Cougar LS Lateral Cage System (2011), 602 descendants of its own
- K101302: Aleutian Ibf System (2010), 595 descendants of its own
- K113348: Cougar System (2011), 591 descendants of its own
- K140319: Coroent TI-C System (2014), 590 descendants of its own

## Indications for use
CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices 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 either a PLIF (CONCORDE), TLIF (CONCORDE, DEVEX, LEOPARD) or 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 CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are 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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation. BENGAL System Indications The BENGAL 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation may be used. The BENGAL 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This 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 this system is intended for use with DePuy Spine supplemental internal fixation.

Source page: https://510kreport.com/device/K081917
Methodology: https://510kreport.com/methodology