Cougar LS 15 Lateral Cage System
by Medos International SARL EUDAMED510(k)
Active
510(k) K122896
Overview
The Cougar LS 15 Lateral Cage System is a spinal interbody device classified as a spinal interbody fusion device (DI 10705034165189) designed for lateral access procedures. Constructed from carbon fiber reinforced PEEK (CFRP), it is intended for placement in the thoracolumbar spine (T1 to L5) to restore structural integrity following vertebral body resection or excision. The cage features a self-distracting tip, bulleted nose, and pyramidal teeth to facilitate insertion and resist migration, ensuring stable positioning within the spinal column.
This system is supplied as a single-use, sterile device and is regulated under FDA 510(k) clearance (K122896) and MDR compliance. The cage dimensions are 15 x 14 x 55mm, and it is intended for use in minimally invasive lateral spine surgeries. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to surgical application.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK122896 | Date18 Oct 2012 | 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- Withdrawn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 is the primary purpose of the Cougar LS 15 Lateral Cage System in spinal surgery?
The Cougar LS 15 Lateral Cage System is designed specifically for lateral access procedures in the thoracolumbar spine (from T1 to L5). Its purpose is to restore structural integrity after vertebral body resection or excision by providing stable support during spinal fusion. The cage’s self-distracting tip, bulleted nose, and pyramidal teeth help ensure proper placement and resist migration, making it ideal for minimally invasive lateral spine surgeries.
Is the Cougar LS 15 Lateral Cage System reusable, or is it intended for single-use only?
The Cougar LS 15 Lateral Cage System is explicitly labeled as a single-use device. This classification aligns with standard sterile medical device protocols, ensuring patient safety and maintaining device integrity for one surgical application only. Reuse is not recommended or supported by the manufacturer.
What are the key dimensions of the Cougar LS 15 Lateral Cage System, and how does this affect its use?
The cage measures 15 x 14 x 55mm, which is optimized for placement in the lateral spine during minimally invasive procedures. These dimensions are tailored to fit within the thoracolumbar spine (T1–L5) while providing sufficient height and length to support vertebral body resection sites. The compact design also facilitates easier insertion through lateral access pathways.
How should the Cougar LS 15 Lateral Cage System be stored to ensure sterility before surgery?
Since the device is sterile and single-use, it must be stored according to standard sterile medical device protocols. This includes keeping it in its original packaging, protecting it from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions. Improper storage could compromise sterility, so always follow the packaging instructions provided.
What materials is the Cougar LS 15 Lateral Cage System made from, and why does this matter?
The cage is constructed from carbon fiber-reinforced PEEK (CFRP), a composite material chosen for its strength, radiolucency (allowing for clear imaging), and biocompatibility. This material combination reduces the risk of artifacts in imaging studies while maintaining structural integrity during spinal fusion. The design also helps minimize stress shielding compared to traditional metal implants.