đź“‹ FDA Reference
Paeon Anterior Cervical Plate System Elatus Lumbar Plate System
Aegis Spine
Summary: The Paeon Anterior Cervical Plate System by Aegis Spine is a medical device used in spinal surgeries to stabilize the cervical spine. It is primarily used by orthopedic and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K223719 ↗
Decision Date ?
January 11, 2023
Product Code ?
KWQ
Device Class ?
Class 2
Evidence ?
0 studies
The Paeon Anterior Cervical Plate System was cleared through the FDA 510(k) pathway on January 11, 2023. It is manufactured by Aegis Spine and classified as a Class 2 device under product code KWQ.
What It Is
The Paeon Anterior Cervical Plate System is designed to provide stability to the cervical spine during the healing process following surgery. It consists of a plate that is affixed to the anterior aspect of the cervical vertebrae using screws. This system helps maintain proper alignment and support of the cervical spine, facilitating fusion and recovery.
FDA-Cleared Indications
- Stabilization of the cervical spine after anterior cervical spine surgery.
- Use with cervical spinal fusion procedures to maintain alignment while fusion heals.
- Use in adult patients requiring anterior cervical stabilization for labeled spinal conditions, including degenerative disease, trauma, or deformity.
Clinical Applications
- Anterior cervical discectomy and fusion (ACDF) with anterior plate fixation.
- Stabilization after removal of a herniated or degenerated cervical disc.
- Anterior fixation of cervical vertebrae during healing after fusion surgery.
- Treatment of labeled cervical spine instability associated with degenerative disease, trauma, or deformity.
Practical Considerations
- The system is available in multiple plate and screw sizes to accommodate cervical anatomy; the surgeon selects the appropriate configuration during surgery.
- It is implanted through an anterior neck approach and fixed to the front of the cervical vertebrae with screws under intraoperative imaging and direct surgical visualization.
- Patients should receive the device-specific instructions regarding implant materials, MRI conditions, and allowable scan parameters; MRI safety cannot be determined from the 510(k) summary alone.
- Contraindications, warnings, and handling requirements should be taken from the manufacturer's current surgical technique guide and labeling.
- The device is intended for use by trained spine surgeons with compatible instruments; implant selection depends on bone quality, spinal alignment, and the planned fusion levels.
Frequently Asked Questions
What is the Paeon Anterior Cervical Plate System used for?
It is used to stabilize the cervical spine during the healing process after surgery, such as in cases of degenerative disc disease or trauma.
What specialties typically use this device?
Orthopedic and neurosurgeons typically use this device in spinal surgeries.
What are the FDA-cleared indications?
The device is indicated for stabilization of the cervical spine in conditions like degenerative disc disease, trauma, and spinal deformities.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.