# K073649: Bengal Stackable Cage System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Jan 25, 2008 after 30 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: 6 generations back to K841189 (1984). 9 ancestors in all.
278 later devices descend from it; 6 cite it directly.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K020522: Modification to Surgical Titanium Mesh System, Depuyacromed (2002) Summary page 1.
- K031635: Depuy Acromed VBR System, Depuyacromed (2003) 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 VBR Spinal 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. The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal 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. The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA TM SR, UNIVERSITY PLATE TM, M-2 ANTERIOR PLATE TM, ISOLA®, VSP@, MOSS®MIAMI, TiMX TM, MONARCH T M, EXPEDIUMTM, VIPER TM, and PROFILE TM ).

Source page: https://510kreport.com/device/K073649
Methodology: https://510kreport.com/methodology