# K103488: Concorde Bullet Cage System

- Pathway: 510(k) (Special)
- Applicant: Johnson and Johnson
- Decided: Mar 2, 2011 after 96 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: 9 generations back to K841189 (1984). 17 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have 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.

## Most influential descendants
- K120966: Depuy Pulse Lumbar Cage System (2012), 25 descendants of its own
- K181397: DualX (2018), 15 descendants of its own
- K203038: Toro-L Interbody Fusion System (2021), 5 descendants of its own
- K173082: Arco™-SA Lumbar Cage System (2018), 5 descendants of its own
- K213355: Toro-L Interbody Fusion System (2022), 4 descendants of its own

## Indications for use
The CONCORDE 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 either a PLIF or TLIF approach using autogenous bone. When used as interbody fusion devices these implants 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 may be used. The CONCORDE and BENGAL System are indicated for use in the thoracolumbar spine (i.e., Ti-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 biomnechanical 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/K103488
Methodology: https://510kreport.com/methodology