# K190284: Bengal Stackable Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Dec 20, 2019 after 312 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- 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: 16 generations back to K003155 (2001). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172032: Modulift Vertebral Body Replacement (VBR) System, Aesculap Implants Systems, Inc. (2017) Summary page 4.
- K073649: Bengal Stackable Cage System, Depuy Spine, Inc. (2008) Summary page 5.
- K140759: Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar LS Lateral, Medos International SARL (2014) Summary page 5.

## Indications for use
The Bengal® Stackable Cage 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 Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Bengal® Stackable Cage 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 Bengal® Stackable Cage System is intended for use with supplemental internal fixation. The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon’s bone graft material of choice. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.

Source page: https://510kreport.com/device/K190284
Methodology: https://510kreport.com/methodology