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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
510K
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.
Clinical Applications
These systems are commonly used in orthopedic and neurosurgical settings for patients suffering from herniated discs, particularly in the lumbar spine. The procedures are often performed in hospitals or specialized surgical centers. Patients who benefit from this technology typically present with symptoms of nerve compression, such as pain, numbness, or weakness in the limbs.
Indications for Use
The FDA-cleared indications for the Acufex Arthroscopic Discectomy Systems involve the treatment of herniated discs, where the device aids in the removal of disc material that is compressing spinal nerves. This is particularly useful for patients experiencing significant pain or neurological symptoms due to disc herniation.
Practical Considerations
When using the Acufex Arthroscopic Discectomy Systems, clinicians should consider the compatibility of the instruments with existing arthroscopic equipment. The systems are designed to be used with standard arthroscopes and require familiarity with minimally invasive surgical techniques. Proper sizing and selection of instruments based on the specific surgical scenario are crucial for optimal outcomes.
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.