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acufex endofix button
Acufex Microsurgical
Summary: The Acufex Endofix Button is a medical device used for soft-tissue graft fixation in surgical procedures, particularly in orthopedic settings. It is primarily used by orthopedic surgeons during anterior cruciate ligament (ACL) reconstruction surgeries.
FDA Clearance Information
Pathway
510K
Number
K922559 ↗
Decision Date
December 24, 1992
Product Code
EBG
Device Class
Class 2
Evidence
0 studies
The Acufex Endofix Button was cleared through the FDA 510k pathway on December 24, 1992. It is manufactured by Acufex Microsurgical and is classified as a Class 2 device under product code EBG.
What It Is
The Acufex Endofix Button is a device designed for the fixation of soft-tissue grafts, commonly used in orthopedic surgeries such as ACL reconstruction. It functions by securing the graft within the bone tunnel, minimizing graft-tunnel motion. This device typically includes a titanium button and polyester tape, providing a reliable method for graft fixation.
Clinical Applications
The Acufex Endofix Button is predominantly used in orthopedic procedures, especially in the context of ACL reconstruction. It is suitable for use in both outpatient and inpatient surgical settings. The device is utilized by orthopedic surgeons to ensure stable fixation of grafts, which is crucial for the success of ligament reconstruction surgeries. It is applicable to a wide range of patient populations undergoing ligament repair.
Indications for Use
The FDA indications for the Acufex Endofix Button involve its use in surgical procedures requiring soft-tissue graft fixation, such as ACL reconstruction. It is intended for patients who need ligament repair following injury or degeneration.
Practical Considerations
The Acufex Endofix Button is available in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard surgical techniques for ACL reconstruction. Surgeons should be familiar with the device's application to ensure optimal outcomes.
Related Literature
The linked study examined the motion of ACL replacement grafts within the femoral bone tunnel when secured by the EndoButton fixation compared to a biodegradable interference screw. The study found that the EndoButton provided effective graft fixation with minimal graft-tunnel motion. However, the study was limited by its focus on a specific surgical technique and patient population, which may not generalize to all clinical scenarios.
Frequently Asked Questions
What is the Acufex Endofix Button used for?
The Acufex Endofix Button is used for soft-tissue graft fixation in surgical procedures, particularly ACL reconstruction.
What specialties typically use this device?
Orthopedic surgeons typically use the Acufex Endofix Button during ligament reconstruction surgeries.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring soft-tissue graft fixation, such as ACL reconstruction.
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.