Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar Ls Lateral
by Medos International SARL EUDAMED510(k)
Active
510(k) K140759
Overview
The device is an intervertebral body fusion system, designed for skeletal fusion in the lumbar spine (L2-S1) or one level in the thoracolumbar region (T1-L5). It comprises modular cages and instrumentation for anterior or oblique placement, facilitating spinal stabilization in degenerative disc disease or other degenerative conditions requiring structural support.
The system is supplied sterile and intended for single-use, with components including polymer/carbon fiber composite or titanium cages. It is regulated under FDA 510(k) clearance (K140759) and MDR compliance, intended for use in orthopedic surgical settings. Sizes and configurations vary by system, and proper storage adheres to manufacturer guidelines for sterile integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK140759 | Date13 Jun 2014 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Medos International SARL
Questions
What spinal regions and conditions is this system approved for use in, and how does it provide stabilization?
This system is designed for skeletal fusion in the lumbar spine (L2-S1) or a single level in the thoracolumbar region (T1-L5). It is intended for patients with degenerative disc disease or other degenerative conditions requiring structural support. The modular cages and instrumentation are placed anteriorly or obliquely to stabilize the spine, promoting fusion by maintaining proper spacing and alignment between vertebrae.
Are the components of this system reusable or single-use, and how should they be stored to maintain sterility?
The components of this system are intended for single-use only. To preserve sterility, storage must follow the manufacturer’s guidelines, which likely include keeping the packaging intact and sealed until use. Avoid exposing the device to moisture, extreme temperatures, or contamination, as these can compromise its sterile integrity.
What materials are the cages made of, and how does this affect their use in spinal fusion?
The cages in this system are constructed from either a polymer/carbon fiber composite or titanium, depending on the specific model. The polymer/carbon fiber composite offers a lightweight option with good biomechanical properties, while titanium provides enhanced strength and biocompatibility—both materials are designed to support spinal fusion while minimizing stress shielding or adverse tissue reactions.
How do I know which system variant (e.g., Bengal, Cougar) is best suited for my patient’s procedure?
The choice between variants like the Bengal System, Cougar System, or Concorde models depends on the surgical approach (anterior vs. oblique) and the specific anatomical requirements of the patient’s case. For example, the Cougar LS Lateral is designed for lateral access, while the Concorde Bullet Lumbar may offer a more compact profile for certain lumbar applications. Consult the manufacturer’s technical documentation or a spine specialist to match the system’s placement characteristics to your patient’s needs.
What regulatory pathways does this device follow, and how does that impact its availability?
This device is cleared under FDA 510(k) (K140759) with a Substantially Equivalent determination by the Orthopedic (OR) Advisory Committee, and it complies with EU MDR (Medical Device Regulation). This means it is legally available in the U.S. and EU markets for its intended orthopedic use, though clinicians should verify local regulatory compliance and hospital procurement policies before use.