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
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in spinal fusion procedures to treat degenerative disc disease.
- Use in spinal fusion procedures for spinal instability, including spondylolisthesis.
- Use to provide intervertebral structural support and stabilization while fusion occurs.
Clinical Applications
- Lumbar interbody fusion for appropriately selected adults with degenerative disc disease.
- Fusion procedures for patients with lumbar spondylolisthesis or other labeled spinal instability.
- Placement of an expandable interbody implant between vertebral bodies to restore or maintain disc-space height and provide structural support.
- Use with compatible navigated instruments and guided or powered drivers during spinal implant placement.
Practical Considerations
- The implant is available in multiple sizes and must be selected and positioned according to the patient's anatomy and the surgical plan.
- Navigation and powered instruments are intended to support surgical guidance and handling; they do not replace direct visualization, imaging, or surgeon judgment.
- MRI safety depends on the complete implanted construct, including the implant, screws, rods, and other components. The applicable Medtronic labeling and MRI conditions should be reviewed before scanning.
- Contraindications, warnings, surgical approach, and patient-selection requirements should be taken from the current FDA-cleared labeling and surgical technique documentation.
- The device is intended for use by trained spine surgeons in an operating-room or surgical-center setting.
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.