# K173787: X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jun 11, 2018 after 179 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K841189 (1984). 200 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080568: X-Mesh Expandable Cage System, Depuy Spine, Inc. (2008) Summary page 12.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 12.
- K140759: Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar LS Lateral, Medos International SARL (2014) Summary page 12.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 12.
- K900138: Motech Titanium Surgical Mesh, Biedermann Motech GmbH (1990) Summary page 12.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 12.
- K020522: Modification to Surgical Titanium Mesh System, Depuyacromed (2002) Summary page 12.
- K030249: Surgical Titanium Mesh System, Depuyacromed (2003) Summary page 12.
- K073649: Bengal Stackable Cage System, Depuy Spine, Inc. (2008) Summary page 12.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 12.
- K103488: Concorde Bullet Cage System, Johnson and Johnson (2011) Summary page 12.
- K110694: Concorde Bullet Spinal System, Johnson & Johnson (2011) Summary page 12.
- K101923: Concorde Curve System, Depuy Spine (2010) Summary page 12.
- K151352: CONCORDE Bullet Spinal System, Medos International SARL (2015) Summary page 12.
- K151773: CONCORDE Bullet Lumbar Interbody System, Medos International SARL (2015) Summary page 12.
- K162327: COUGAR® LS Lateral Cage System and COUGAR® System, Medos International SARL (2016) Summary page 12.
- K031635: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 12.
- K120517: Depuy Pulse Cervical Cage System, Medos International SARL (2012) Summary page 12.
- K120966: Depuy Pulse Lumbar Cage System, Medos International SARL (2012) Summary page 12.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 12.

## Most influential descendants
- K192214: CarboClear VBR System (2019), 1 descendant of its own
- K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System (2023), 0 descendants of its own

## Indications for use
The Vertebral Body Replacement (VBR) Spinal Systems are indicated for use in the thoracolumbar spine (i.e., T1 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. The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal 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. The VBR Spinal Systems are intended for use with DePuy Spine supplemental internal fixation. 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 products 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 products. The CONCORDE Bullet and COUGAR 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 (L.2-S1). Additionally the CONCORDE Bullet and COUGAR Systems can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 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 or TLIF approach (CONCORDE Bullet) or an anterior approach (COUGAR) using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products. The CONCORDE Bullet and COUGAR 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 products. The CONCORDE, CONCORDE Inline, CONCORDE Curve, 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, CONCORDE Inline) or TLIF (CONCORDE, CONCORDE Inline, CONCORDE Curve, DEVEX, LEOPARD) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products. The CONCORDE, CONCORDE Inline, CONCORDE Curve, 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 products. The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 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 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. The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion 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 from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the COUGAR LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation. The DePuy PULSE Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck 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. The DePuy PULSE Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. DePuy PULSE Cervical Cage System implants are intended to be used with supplemental internal fixation systems. The DePuy PULSE Lumbar Cage System is 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 a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products. The Lumbar I/F Cage System is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360° fusion) and posterior pedicle screw fixation. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

Source page: https://510kreport.com/device/K173787
Methodology: https://510kreport.com/methodology