đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For surgical procedures involving the meniscus of the knee.
- For debridement, smoothing, or contouring of meniscal tissue during orthopedic surgery.
Clinical Applications
- Arthroscopic treatment of meniscal tears.
- Debridement of damaged meniscal tissue.
- Smoothing and contouring the meniscal surface during knee surgery.
- Use by orthopedic surgeons with standard arthroscopic surgical equipment.
Practical Considerations
- The rasps are available in different sizes and configurations; the surgeon selects the instrument based on the anatomy and surgical approach.
- They are manual instruments used through or alongside standard arthroscopic equipment and require appropriate surgical training.
- The device is intended for controlled tissue abrasion and should be handled carefully to avoid removing more tissue than planned.
- The FDA record identifies a Class II device under product code HRX; the available record does not provide an MRI safety classification.
- Contraindications, sterilization requirements, reuse instructions, and instrument-specific warnings should be confirmed in the current manufacturer labeling.
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.