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catalyft ls expandable interbody system with titan nanolock surface technology
Medtronic Sofamor Danek U
Summary: The Catalyft LS Expandable Interbody System is a spinal implant used in lumbar fusion surgeries. It is primarily used by orthopedic and neurosurgeons to treat degenerative disc disease.
FDA Clearance Information
Pathway
510K
Number
K223153 ↗
Decision Date
December 16, 2022
Product Code
MAX
Device Class
Class 2
Evidence
0 studies
The Catalyft LS Expandable Interbody System was cleared through the FDA 510(k) pathway on December 16, 2022. Manufactured by Medtronic Sofamor Danek, it is classified as a Class 2 device.
What It Is
The Catalyft LS Expandable Interbody System is an expandable spinal implant designed to aid in lumbar fusion surgeries. It features Titan NanoLOCK Surface Technology, which enhances osseointegration and stability. The device is used to restore disc height and provide structural support in the lumbar spine, facilitating bone growth and fusion.
Clinical Applications
This device is commonly used in spinal fusion procedures for patients with degenerative disc disease, spondylolisthesis, or spinal stenosis. Orthopedic and neurosurgeons typically use it in hospital or specialized surgical center settings. It is suitable for adult patients requiring lumbar interbody fusion to alleviate pain and improve spinal stability.
Indications for Use
The FDA-cleared indications include use in patients with degenerative disc disease to stabilize the spine and promote fusion. It is intended for those who require surgical intervention to address lumbar spine instability or deformity.
Practical Considerations
The Catalyft LS system offers various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard surgical instruments used in spinal fusion procedures. Surgeons should be familiar with expandable interbody devices and their deployment techniques.
Frequently Asked Questions
What is Catalyft LS Expandable Interbody System used for?
It is used for lumbar spinal fusion surgeries to treat conditions like degenerative disc disease and stabilize the spine.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons typically use this device in spinal fusion procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients with degenerative disc disease to stabilize the lumbar spine and promote fusion.
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.