Interbody Cage System
by Aurora Spine
510(k) K133967
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133967 | Date31 Jan 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 19 Sep 2026
The Interbody Cage System is a spinal interbody fusion device designed to provide structural support and promote spinal fusion in the cervical or thoracolumbar spine. Constructed from PEEK, it is intended for placement between vertebral bodies to maintain disc height, restore spinal alignment, and facilitate bone growth across the intervertebral space.
This system is supplied as a single-use device and is used in surgical procedures under sterile conditions. The cages feature a self-distracting nose and teeth on the inferior and superior surfaces to enhance stability and reduce the risk of retropulsion. Authorized for use in the United States under an FDA 510(k) clearance (K133967), the device is classified under the product code MAX and reviewed by the Orthopedic (OR) Advisory Committee.
Other devices from Aurora Spine, Inc.
Questions
AI-generated answers, 19 Sep 2026
What materials is the Interbody Cage System made from and why does that matter for spinal fusion procedures?
The Interbody Cage System is constructed from polyetheretherketone (PEEK), a biocompatible polymer known for its radiolucency, strength, and ability to integrate with bone. This material choice helps maintain spinal alignment while allowing for clear imaging post-surgery, which is critical for monitoring fusion progress and ensuring long-term stability.
How is the Interbody Cage System designed to improve stability during spinal fusion, and what features help prevent complications?
The system includes a self-distracting nose to facilitate proper placement between vertebrae, while teeth on the superior and inferior surfaces create a secure grip to prevent slippage or retropulsion. These features enhance stability, reducing the risk of cage migration and improving fusion outcomes in both cervical and thoracolumbar applications.
Is the Interbody Cage System reusable, and if not, what considerations should be taken for single-use devices in the operating room?
The Interbody Cage System is explicitly designed for single-use only, requiring sterile packaging and handling per surgical protocols. This ensures patient safety by eliminating cross-contamination risks and maintains device integrity, as reuse could compromise structural integrity or sterility, potentially leading to complications.
What spinal regions is this device approved for, and how does the design accommodate different anatomical needs?
The Interbody Cage System is authorized for use in both the cervical and thoracolumbar spine, with a modular design allowing for precise sizing and alignment. The self-distracting nose and teeth enhance adaptability to varying vertebral body shapes, ensuring proper disc height restoration and spinal stabilization across these regions.
How should the Interbody Cage System be stored to preserve its performance and sterility before use?
Since it is a single-use, sterile device, the Interbody Cage System must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and prevents degradation of the PEEK material, maintaining its structural integrity until surgical use.