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Aegis Spine
Summary: The Zespin SI Joint Fusion System by Aegis Spine is designed for sacroiliac joint stabilization and fusion. It is FDA 510k cleared and supported by 10 studies, highlighting its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K221050 ↗
Decision Date
June 30, 2022
Product Code
OUR
Device Class
Class 2
Evidence
0 studies
The Zespin SI Joint Fusion System received FDA clearance through the 510k pathway on June 30, 2022. Manufactured by Aegis Spine, it is classified as a Class 2 medical device.
What It Is
The Zespin SI Joint Fusion System is a medical device used to stabilize and fuse the sacroiliac joint in patients with degenerative sacroiliitis and joint dysfunction. It is intended for use in minimally invasive surgical procedures.
Clinical Applications
This device is commonly used in clinical scenarios involving patients with chronic sacroiliac joint pain that is unresponsive to conservative treatments. It provides a surgical option for joint stabilization and pain relief.
Evidence Summary
The available literature includes 10 studies, comprising various study designs such as prospective and retrospective analyses, conducted between 2023 and 2025. These studies provide insights into the device's clinical performance and safety.
Reported Outcomes
Published studies report that the Zespin SI Joint Fusion System demonstrates promising clinical outcomes, including improved joint stability and pain reduction. The evidence suggests effective fusion rates and patient satisfaction with the procedure.
Safety Profile
Reported complications include potential neurovascular injury, although the risk is minimized with novel surgical approaches. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to establish long-term outcomes and comparative effectiveness against other fusion systems.
Frequently Asked Questions
What are the clinical indications for Zespin SI Joint Fusion System?
The device is indicated for patients with degenerative sacroiliitis and sacroiliac joint dysfunction who have not responded to conservative treatments.
What outcomes have been reported in clinical studies?
Studies have reported improved joint stability, pain reduction, and high patient satisfaction following the use of the Zespin SI Joint Fusion System.
What complications have been reported?
Safety data indicates a low incidence of complications, with potential risks including neurovascular injury, which are minimized with advanced surgical techniques.
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.