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acufex meniscal rasps
Acufex Microsurgical
Summary: The Acufex Meniscal Rasps are surgical tools used primarily in orthopedic procedures to smooth and contour meniscal tissue. They are utilized by orthopedic surgeons during knee surgeries to treat meniscal tears.
FDA Clearance Information
Pathway
510K
Number
K932460 ↗
Decision Date
March 22, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Meniscal Rasps were cleared through the FDA 510(k) pathway on March 22, 1994. Manufactured by Acufex Microsurgical, this device is classified as Class 2 under product code HRX.
What It Is
The Acufex Meniscal Rasps are precision surgical instruments designed to assist in the debridement and shaping of the meniscus during arthroscopic knee surgery. These rasps help orthopedic surgeons to smooth out the meniscal surface, facilitating better healing and reducing the risk of further injury. The device's design allows for effective manipulation and contouring of the meniscal tissue.
Clinical Applications
Commonly used in orthopedic settings, the Acufex Meniscal Rasps are employed during arthroscopic knee surgeries, particularly for patients with meniscal tears. These procedures are typically performed in hospitals or specialized surgical centers. The device is used on a wide range of patients, from athletes to older adults, who suffer from meniscal damage due to injury or degenerative conditions.
Indications for Use
The FDA-cleared indications suggest that the Acufex Meniscal Rasps are intended for use in procedures involving the meniscus, a common site of injury in the knee. They are particularly useful for patients with meniscal tears that require surgical intervention to restore knee function.
Practical Considerations
The Acufex Meniscal Rasps come in various sizes to accommodate different patient anatomies and surgical needs. They are compatible with standard arthroscopic equipment and require careful handling to ensure precision during surgery. Surgeons should be familiar with the technique for optimal outcomes.
Frequently Asked Questions
What is Acufex Meniscal Rasps used for?
The Acufex Meniscal Rasps are used to smooth and contour the meniscal tissue during arthroscopic knee surgeries, particularly for treating meniscal tears.
What specialties typically use this device?
Orthopedic surgeons specializing in sports medicine and knee surgeries typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the meniscus, such as treating meniscal tears during knee surgeries.
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.