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Anteralign Ls Spinal System with Titan Nanolock Surface Technology Mazorx Stealth Tm Edition
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 ?
510(k)
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.
FDA-Cleared Indications
- Spinal stabilization using implanted fixation components during spinal surgery.
- Use in conjunction with spinal fusion procedures when internal fixation is indicated.
- Use under the conditions, spinal levels, patient ages, and surgical approaches specified in the device's FDA-cleared labeling.
Clinical Applications
- Instrumented spinal fusion requiring implant-based stabilization.
- Stabilization of the spine after surgical correction of an indicated spinal condition.
- Use with compatible surgical navigation or robotic guidance systems, including the MAZOR X Stealth Edition workflow, when specified by the labeling.
- Use of spinal fixation components selected for the patient's anatomy and the planned surgical approach.
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.
Practical Considerations
- The system includes multiple implant sizes and configurations; selection depends on spinal anatomy, surgical approach, fixation levels, and the patient's condition.
- It must be used with compatible components and instruments according to the manufacturer's instructions. Mixing implants from different systems may be unsafe unless specifically authorized by the labeling.
- MRI conditions depend on the complete implanted construct and the manufacturer's current MRI safety labeling. Patients should provide the implant information to the MRI facility before scanning.
- Contraindications and warnings may include active infection, inadequate bone quality, allergy or sensitivity to implant materials, and inability to follow postoperative restrictions; the full labeling should be reviewed.
- Implant placement is performed with imaging guidance and may be integrated with navigation or robotic assistance. The implant does not replace the need for appropriate decompression, fusion, medication, physical therapy, or revision surgery when clinically indicated.
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.