đź“‹ FDA Reference
catalyft pl expandable interbody system navigated instruments anteralign tl spinal system with titan nanolock surface technology navigated instruments and cd horizon solera voyager spinal system navigated guided and powered drivers
Medtronic Sofamor Danek U
Summary: The Catalyft PL Expandable Interbody System is a spinal implant used in spinal fusion surgeries, primarily by orthopedic and neurosurgeons. It is designed to provide structural stability and support during the healing process.
FDA Clearance Information
Pathway
510K
Number
K214011 ↗
Decision Date
February 9, 2022
Product Code
OLO
Device Class
Class 2
Evidence
0 studies
The Catalyft PL Expandable Interbody System was cleared through the FDA 510(k) pathway on February 9, 2022. It is manufactured by Medtronic Sofamor Danek U and classified as a Class 2 medical device.
What It Is
The Catalyft PL Expandable Interbody System is a spinal implant designed to be used in spinal fusion procedures. It features an expandable design that allows for optimal fit and stability in the intervertebral space. The system includes navigated instruments for precise placement and is enhanced with Titan NanoLOCK surface technology to promote bone growth and fusion.
Clinical Applications
This device is commonly used in spinal fusion surgeries, particularly for patients with degenerative disc disease, spondylolisthesis, or other spinal instabilities. It is typically utilized in hospital or surgical center settings by orthopedic surgeons and neurosurgeons. The system is suitable for adult patients requiring spinal stabilization and fusion.
Indications for Use
The FDA-cleared indications for this device include use in spinal fusion procedures to treat conditions such as degenerative disc disease and spondylolisthesis. It is intended for patients who require stabilization of the spine to facilitate bone fusion.
Practical Considerations
The Catalyft PL system is available in various sizes to accommodate different patient anatomies. It is compatible with navigated and powered drivers for precise placement. Surgeons should be familiar with the expandable nature of the implant and ensure proper sizing and positioning during surgery.
Frequently Asked Questions
What is the Catalyft PL Expandable Interbody System used for?
It is used in spinal fusion surgeries to provide stability and support for the spine during the healing process.
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 spinal fusion procedures to treat conditions like degenerative disc disease and spondylolisthesis.
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.