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adaptix interbody system with titan nanolock surface technology
Medtronic Sofamor Danek U
Summary: The Adaptix Interbody System with Titan NanoLOCK Surface Technology is a spinal implant used in spinal fusion surgeries. It is typically utilized by orthopedic and neurosurgeons to treat degenerative disc disease and other spinal conditions.
FDA Clearance Information
Pathway
510K
Number
K250669 ↗
Decision Date
April 22, 2025
Product Code
MAX
Device Class
Class 2
Evidence
0 studies
The Adaptix Interbody System was cleared through the FDA's 510(k) pathway on April 22, 2025. Manufactured by Medtronic Sofamor Danek, it is classified as a Class 2 medical device.
What It Is
The Adaptix Interbody System is a spinal implant designed to facilitate spinal fusion. It features Titan NanoLOCK Surface Technology, which enhances bone growth and integration with the implant. This system is used to stabilize the spine by replacing damaged intervertebral discs, providing structural support and promoting fusion between vertebrae.
Clinical Applications
Commonly used in spinal fusion surgeries, this device is employed in the treatment of conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis. It is primarily used by orthopedic surgeons and neurosurgeons in hospital settings. Patients typically include adults with chronic back pain or instability requiring surgical intervention.
Indications for Use
The FDA indications suggest that this device is intended for patients needing spinal fusion, often due to degenerative disc disease or other spinal pathologies. It is suitable for those who have not responded to conservative treatments.
Practical Considerations
The Adaptix Interbody System comes in various sizes to accommodate different patient anatomies. It is compatible with standard surgical instruments used in spinal fusion procedures. Surgeons should be familiar with the specific implantation techniques recommended by the manufacturer.
Frequently Asked Questions
What is Adaptix Interbody System used for?
It is used in spinal fusion surgeries to treat conditions like degenerative disc disease and provide spinal stability.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use this device in spinal surgery.
What are the FDA-cleared indications?
The device is indicated for spinal fusion in patients with degenerative disc disease and other spinal conditions requiring surgical intervention.
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.