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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 system used primarily for spinal stabilization. Key evidence highlights its role in improving outcomes in spinal surgeries.
FDA Clearance Information
Pathway
510K
Number
K212524 ↗
Decision Date
December 8, 2021
Product Code
MAX
Device Class
Class 2
Evidence
0 studies
The Anteralign Spinal System was cleared by the FDA via the 510(k) pathway on December 8, 2021. 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 provide stabilization and support during spinal fusion surgeries. It features Titan NanoLock Surface Technology, which enhances osseointegration and implant stability.
Clinical Applications
This device is commonly used in spinal fusion procedures to treat conditions such as degenerative disc disease, scoliosis, and other spinal deformities. It is particularly useful in cases requiring enhanced stability and fusion support.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2015 to 2023, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report improvements in spinal stability and patient outcomes following the use of the Anteralign Spinal System. The device has shown efficacy in reducing pain and enhancing mobility in patients undergoing spinal fusion surgeries.
Safety Profile
Reported complications include rod fractures and adverse events related to spinal fusion procedures. However, the overall safety profile is consistent with other spinal implant systems.
Evidence Limitations
Current evidence is limited by the heterogeneity of study populations and the variability in follow-up durations. Further research is needed to assess long-term outcomes and to better understand the risk factors associated with device-related complications.
Frequently Asked Questions
What are the clinical indications for Anteralign Spinal System?
The Anteralign Spinal System is indicated for use in spinal fusion surgeries to treat conditions such as degenerative disc disease and scoliosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported improvements in spinal stability, pain reduction, and enhanced mobility following the use of the Anteralign Spinal System.
What complications have been reported?
Safety data from evidence indicate complications such as rod fractures and other adverse events typical of 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.