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anteralign spinal system with titan nanolock surface technology
Medtronic Sofamor Danek U
Summary: The anteralign spinal system with Titan NanoLock surface technology is a spinal implant device used primarily for spinal fusion procedures. Key evidence highlights its role in improving spinal stability and potential benefits in spinal deformity correction.
FDA Clearance Information
Pathway
510K
Number
K214010 ↗
Decision Date
April 12, 2022
Product Code
MAX
Device Class
Class 2
Evidence
0 studies
The anteralign spinal system was cleared by the FDA through the 510(k) pathway on April 12, 2022. It is manufactured by Medtronic Sofamor Danek U and classified as a Class 2 device.
What It Is
The anteralign spinal system is a spinal implant designed to enhance spinal stability and facilitate fusion in patients undergoing spinal surgery. It features Titan NanoLock surface technology, which aims to promote bone growth and integration.
Clinical Applications
This device is commonly used in spinal fusion surgeries, particularly in cases of spinal deformities such as scoliosis or degenerative disc disease. It is intended to provide mechanical support and facilitate bone fusion.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and prospective cohorts, conducted between 2015 and 2023. These studies explore the device's efficacy and safety in spinal applications.
Reported Outcomes
Published studies report that the anteralign spinal system is effective in enhancing spinal stability and promoting fusion in patients with spinal deformities. Outcomes include improved alignment and reduced pain in patients undergoing spinal fusion procedures.
Safety Profile
Reported complications include rod fractures and adverse events associated with spinal fusion surgeries. The safety profile is consistent with other spinal implant devices, with complications generally related to surgical technique and patient factors.
Evidence Limitations
Current evidence is limited by heterogeneous study populations and varying follow-up durations. Further research is needed to establish long-term outcomes and optimize patient selection criteria.
Frequently Asked Questions
What are the clinical indications for anteralign spinal system?
The device is indicated for use in spinal fusion surgeries, particularly in patients with spinal deformities or degenerative disc disease.
What outcomes have been reported in clinical studies?
Studies report improved spinal stability, alignment, and pain reduction in patients undergoing spinal fusion with the device.
What complications have been reported?
Safety data indicate complications such as rod fractures and typical surgical risks associated with spinal fusion procedures.
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.