📊 Evidence-Based Reference
Anteralign Spinal System with Titan Nanolock Surface Technology
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in spinal fusion procedures to provide mechanical stabilization and support for fusion.
- Use in the treatment of spinal conditions for which an interbody or spinal fixation implant is indicated under the device's FDA-cleared labeling.
Clinical Applications
- Spinal fusion surgery requiring implant-based stabilization.
- Interbody or related spinal reconstruction procedures when the system's labeled components are appropriate.
- Treatment of selected degenerative spinal conditions requiring fusion.
- Treatment of selected spinal deformities requiring surgical stabilization.
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.
Practical Considerations
- The system includes implant components in different configurations and sizes; the surgeon selects components based on spinal anatomy, the surgical approach, and the planned fusion levels.
- Titan NanoLock is a surface technology intended to support bone integration; it does not replace the need for appropriate surgical preparation, alignment, fixation, and postoperative fusion care.
- MRI safety depends on the exact implanted components and the manufacturer's current MRI conditions. The implant card and device-specific MRI labeling should be reviewed before scanning.
- Contraindications and precautions may include active infection, inadequate bone quality or quantity, allergy or sensitivity to implant materials, and conditions that could prevent successful fusion or safe spinal surgery.
- The device is implanted during surgery, typically with fluoroscopic or other intraoperative imaging, and may be used with additional spinal fixation hardware when specified by the labeling.
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.