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anteralign ls spinal system with titan nanolock surface technology mazorx stealth tm edition
Medtronic Sofamor Danek U
Summary: The Anteralign LS Spinal System with Titan NanoLOCK Surface Technology is a spinal implant system designed for spinal stabilization. It is primarily used in spinal surgeries and has been FDA-cleared. Key evidence includes studies on its application in spinal procedures.
FDA Clearance Information
Pathway
510K
Number
K222383 ↗
Decision Date
September 29, 2022
Product Code
OLO
Device Class
Class 2
Evidence
0 studies
The Anteralign LS Spinal System was cleared through the FDA 510(k) pathway on September 29, 2022. Manufactured by Medtronic Sofamor Danek U, it is classified as a Class 2 device.
What It Is
The Anteralign LS Spinal System is a spinal implant system featuring Titan NanoLOCK Surface Technology. It is intended for use in spinal stabilization procedures, providing support and alignment to the spine during surgical interventions.
Clinical Applications
Commonly used in spinal surgeries, this device is applied in scenarios requiring spinal stabilization and alignment. It is particularly relevant in cases of spinal deformities or injuries requiring surgical intervention.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and prospective analyses. The studies span a range of clinical applications and were published in 2025.
Reported Outcomes
Published studies report varied outcomes related to the efficacy of the Anteralign LS Spinal System. These include improvements in spinal alignment and stabilization during surgical procedures. However, specific quantitative outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include general surgical risks associated with spinal procedures. The evidence provided does not detail specific adverse events related to the device itself.
Evidence Limitations
The current evidence lacks detailed quantitative outcomes and specific safety data related to the Anteralign LS Spinal System. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for the Anteralign LS Spinal System?
The device is indicated for use in spinal stabilization procedures, particularly in cases requiring surgical intervention for spinal alignment.
What outcomes have been reported in clinical studies?
Studies report improvements in spinal alignment and stabilization, though specific quantitative outcomes are not detailed.
What complications have been reported?
General surgical risks are noted, but specific complications related to the device are not detailed in the provided evidence.
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.