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acufex endobutton pack
Acufex Microsurgical
Summary: The Acufex Endobutton Pack is a surgical device used primarily in orthopedic procedures, particularly for ligament reconstruction. It is utilized by orthopedic surgeons to secure grafts during surgeries.
FDA Clearance Information
Pathway
510K
Number
K951859 ↗
Decision Date
June 9, 1995
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Endobutton Pack was cleared through the FDA 510(k) pathway on June 9, 1995. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Endobutton Pack is a surgical device designed for use in ligament reconstruction procedures, such as anterior cruciate ligament (ACL) repair. It functions as a fixation device, providing a secure method for attaching grafts to bone. The device is typically used in minimally invasive arthroscopic surgeries, offering reliable support and stability to the reconstructed ligament.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in sports medicine for ACL reconstruction. It is employed in both hospital and outpatient surgical settings. The primary patient population includes athletes and individuals with ligament injuries requiring surgical intervention. The device is favored for its ease of use and effectiveness in securing soft tissue grafts.
Indications for Use
The FDA indications suggest that the Acufex Endobutton Pack is intended for use in procedures requiring ligament fixation, such as ACL reconstruction. It is suitable for patients with ligament tears or injuries needing surgical repair.
Practical Considerations
The Acufex Endobutton Pack comes in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard arthroscopic equipment and techniques. Surgeons should be familiar with the specific insertion technique to ensure optimal outcomes.
Frequently Asked Questions
What is the Acufex Endobutton Pack used for?
It is used for ligament fixation in orthopedic surgeries, particularly ACL reconstruction.
What specialties typically use this device?
Orthopedic surgeons, especially those specializing in sports medicine, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in ligament reconstruction procedures, such as ACL repair.
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.