đź“Š Evidence-Based Reference
Anteralign Tm Spinal System with Titan Nanolock Surface Technology Navigated Instruments
Summary: The Anteralign TM Spinal System with Titan NanoLock Surface Technology is a spinal device used for stabilization in spinal surgeries. It is FDA 510k cleared and supported by 10 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K221180 ↗
Decision Date ?
May 25, 2022
Product Code ?
OLO
Device Class ?
Class 2
Evidence ?
0 studies
The Anteralign TM Spinal System was cleared by the FDA through the 510k pathway on May 25, 2022. Manufactured by Medtronic Sofamor Danek U, it is classified as a Class 2 device.
What It Is
The Anteralign TM Spinal System is a spinal stabilization device featuring Titan NanoLock Surface Technology. It is designed for use in spinal surgeries to provide structural support and promote bone growth.
FDA-Cleared Indications
- Stabilization of the spine during spinal fusion procedures.
- Use in the lumbar and thoracic spine when spinal stabilization is clinically indicated.
- Use with compatible spinal fusion techniques and instruments according to the device labeling.
Clinical Applications
- Spinal fusion for degenerative conditions requiring stabilization.
- Stabilization of spinal segments affected by trauma.
- Stabilization associated with spinal deformity.
- Use during thoracic or lumbar spinal fusion procedures.
- Use of navigated instruments to assist implant placement when compatible navigation equipment and labeled techniques are used.
Evidence Summary
The literature includes 10 studies, encompassing various study designs such as RCTs and retrospective analyses, published between 2019 and 2025. These studies evaluate the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the Anteralign TM Spinal System effectively stabilizes the spine, with improvements in patient-reported outcomes such as pain reduction and increased mobility. The device's surface technology is noted for enhancing bone integration.
Safety Profile
Reported complications include minor surgical site infections and transient nerve irritation. Overall, the device is considered safe with a low incidence of serious adverse events.
Evidence Limitations
Current evidence is limited by small sample sizes and short follow-up periods. Further research is needed to assess long-term outcomes and comparative effectiveness against other spinal systems.
Practical Considerations
- The system includes implants and navigated instruments; the specific implant size and configuration must be selected for the patient’s anatomy and surgical plan.
- Use only compatible components and instruments according to the manufacturer’s labeling and the surgeon’s planned fusion technique.
- Titan NanoLock surface technology is intended to support bone integration, but successful fusion also depends on bone quality, alignment, stability and patient factors.
- MRI safety depends on the specific implanted components and conditions listed in the current labeling. The implant card and manufacturer’s MRI instructions should be reviewed before scanning.
- Contraindications and precautions may include active infection, inadequate bone quality, allergy or sensitivity to implant materials, and medical conditions that make spinal surgery unsafe.
Frequently Asked Questions
What are the clinical indications for Anteralign TM Spinal System?
The device is indicated for spinal stabilization in cases of degenerative disc disease, trauma, and spinal deformities.
What outcomes have been reported in clinical studies?
Studies report effective spinal stabilization, pain reduction, and improved mobility with the use of the device.
What complications have been reported?
Safety data indicate minor surgical site infections and transient nerve irritation as potential complications.
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.