Vertiflex Spinous Process Fixation Plate
by Vertiflex, Inc. 510(k)
Active
510(k) K122509
Overview
The Vertiflex Spinous Process Fixation Plate is a one-piece bilateral locking plate system classified as a spinal fixation device. It is designed for posterior, non-pedicle supplemental fixation in the non-cervical spine, attaching to adjacent spinous processes to promote spinal fusion.
Implanted via conventional or minimally invasive techniques, the plate is constructed from titanium 6AL-4V alloy and available in multiple sizes to match anatomical requirements. Supplied sterile for single-use, it carries an FDA 510(k) clearance under the Traditional review pathway, with a K-number of K122509.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122509 | Date17 Dec 2012 | 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- Withdrawn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
- KWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vertiflex, Inc.
Questions
What is the primary purpose of the Vertiflex Spinous Process Fixation Plate, and how does it differ from traditional spinal fixation methods?
The Vertiflex Spinous Process Fixation Plate is designed for posterior, non-pedicle supplemental fixation in the non-cervical spine, meaning it attaches to adjacent spinous processes rather than pedicles. This makes it a targeted solution for promoting spinal fusion without the need for pedicle screws, which can be beneficial in cases where pedicle fixation is not feasible or desired. It is intended as an adjunct to existing spinal stabilization techniques, not a standalone primary fixation system.
Is the Vertiflex Spinous Process Fixation Plate reusable, or is it meant for single-use only?
The device is supplied sterile for single-use only, as explicitly stated in the product description. This ensures patient safety and compliance with medical device sterilization standards, preventing cross-contamination risks associated with reuse.
What materials is the Vertiflex Spinous Process Fixation Plate made from, and why does this matter?
The plate is constructed from titanium 6AL-4V alloy, a biocompatible material commonly used in spinal implants due to its strength, corrosion resistance, and compatibility with the human body. This choice minimizes the risk of adverse reactions while providing durability for long-term spinal stabilization.
How many sizes are available for the Vertiflex Spinous Process Fixation Plate, and how does this accommodate different patients?
The device is available in multiple sizes to match anatomical requirements, ensuring a precise fit for various spinal anatomies. This modularity allows surgeons to select the appropriate plate length and configuration for optimal fixation during procedures, whether performed via conventional or minimally invasive techniques.
What regulatory pathway was followed for FDA clearance of the Vertiflex Spinous Process Fixation Plate, and what does this mean for clinicians?
The device received FDA 510(k) clearance under the Traditional review pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device (determined as substantially equivalent). This clearance was granted by the Orthopedic (OR) Advisory Committee, ensuring it meets established standards for spinal fixation devices. Clinicians can rely on this approval as evidence of the device’s regulatory compliance and intended use for supplemental posterior fixation.