Axis Anterior Cervical Plate System
by Axis Orthopaedics 510(k)
Active
510(k) K173867
Overview
The Axis Anterior Cervical Plate System is an orthopedic spinal fixation device classified as an anterior cervical plate (product code KWQ). It consists of titanium alloy (Ti-6Al-4V ELI) plates and screws designed to provide mechanical support to the cervical spine, aiding in spinal fusion procedures. The plates incorporate a pre-lordotic curve to conform to cervical anatomy and feature an integrated locking mechanism for fixed and variable angled screws.
This system is intended for use in the operating room by surgeons performing anterior cervical spine procedures. It is supplied as a sterile, single-use device and has received FDA 510(k) clearance under the Traditional 510(k) review pathway. The device is manufactured by Axis Orthopaedics and is regulated under the Orthopedic advisory committee classification. No MRI safety information is specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173867 | Date5 Apr 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Axis Orthopaedics
Questions
What materials are used in the Axis Anterior Cervical Plate System, and why is this important for spinal fusion procedures?
The Axis Anterior Cervical Plate System is made from titanium alloy (Ti-6Al-4V ELI), a biocompatible material known for its strength, corrosion resistance, and compatibility with bone tissue. This choice is critical for spinal fusion procedures because it minimizes the risk of adverse reactions, ensures long-term stability, and supports proper osseointegration—helping the spine heal securely while maintaining structural integrity.
Is the Axis Anterior Cervical Plate System designed for reuse, or is it intended for single-use only? How does this affect its clinical use?
The Axis Anterior Cervical Plate System is explicitly supplied as a sterile, single-use device. This design ensures patient safety by eliminating the risk of cross-contamination between procedures, which is particularly important in spinal surgery where infection control is paramount. Single-use also simplifies inventory management and reduces the need for reprocessing, streamlining workflow in the operating room.
What anatomical features of the Axis Anterior Cervical Plate System make it suitable for cervical spine procedures?
The system incorporates a pre-lordotic curve, which matches the natural curvature of the cervical spine, providing better anatomical conformity and load distribution. Additionally, the plates feature an integrated locking mechanism for both fixed and variable angled screws, allowing surgeons to achieve precise fixation tailored to the patient’s specific cervical anatomy. This design enhances stability during fusion while accommodating individual surgical needs.
How is the Axis Anterior Cervical Plate System regulated, and what does the FDA’s Traditional 510(k) pathway indicate about its approval process?
The device was cleared via the FDA’s Traditional 510(k) review pathway, meaning its manufacturer demonstrated that it is substantially equivalent to a legally marketed predicate device already on the market. This pathway involves a detailed submission to the FDA, including clinical and technical data, to ensure safety and effectiveness. The clearance under this route indicates that the device underwent rigorous evaluation by the Orthopedic Advisory Committee before approval.
Are there any special storage requirements for the Axis Anterior Cervical Plate System, and how should it be handled before use?
Since the system is sterile and single-use, it must be stored in its original packaging to maintain sterility until use. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, the device should be used immediately in the operating room to prevent contamination. Proper handling ensures compliance with surgical protocols and patient safety standards.