đź“‹ FDA Reference
Acufex Arthroscopic Discectomy Systems
Acufex Microsurgical
Summary: The Acufex Arthroscopic Discectomy Systems are surgical tools used primarily for minimally invasive spinal procedures. They are typically utilized by orthopedic surgeons and neurosurgeons to remove herniated disc material.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K941709 ↗
Decision Date ?
April 14, 1995
Product Code ?
HRX
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Arthroscopic Discectomy Systems were cleared through the FDA 510(k) pathway on April 14, 1995. Manufactured by Acufex Microsurgical, this device is classified as a Class 2 medical device under product code HRX.
What It Is
The Acufex Arthroscopic Discectomy Systems are specialized surgical instruments designed for arthroscopic discectomy procedures. These systems enable surgeons to perform minimally invasive spinal surgeries by providing tools that allow precise removal of herniated disc material through small incisions. The systems typically include a variety of instruments such as graspers, cutters, and probes, which are used in conjunction with an arthroscope to visualize and treat the affected area.
FDA-Cleared Indications
- Used during arthroscopic discectomy for removal of herniated intervertebral disc material.
- Intended to assist surgical treatment of disc herniation causing compression of nearby spinal nerves.
Clinical Applications
- Removal of herniated disc material during an arthroscopic discectomy.
- Use with an arthroscope to visualize and access the affected disc region.
- Grasping, cutting, probing, or extracting disc material during minimally invasive spinal surgery.
- Treatment of appropriately selected symptomatic disc herniation when surgical decompression is indicated.
Practical Considerations
- The instruments should be used only by clinicians trained in arthroscopic spinal procedures and according to the device labeling.
- Confirm compatibility with the arthroscope, cannula, visualization system, and other operating-room equipment before the procedure.
- Select the instrument type and size based on the surgical approach, anatomy, and amount and location of disc material.
- The record provided does not establish MRI safety; MRI conditions should be confirmed from the current manufacturer labeling before scanning a patient with retained or implanted components.
- Patient selection should account for alternative treatments, including medication, physical therapy, injections, open or microscopic surgery, and the patient's neurologic status.
Frequently Asked Questions
What is Acufex Arthroscopic Discectomy Systems used for?
They are used for minimally invasive removal of herniated disc material in the spine.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use these systems.
What are the FDA-cleared indications?
The systems are indicated for the removal of herniated disc material that is compressing spinal nerves.
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.