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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 ?
510(k)
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.
FDA-Cleared Indications
- Fixation of soft-tissue grafts during orthopedic reconstructive surgery.
- Fixation of soft-tissue grafts in procedures such as ACL reconstruction.
Clinical Applications
- Securing a soft-tissue graft at the bone tunnel during ACL reconstruction.
- Providing cortical fixation for ligament-reconstruction grafts.
- Use during open or arthroscopic orthopedic ligament-reconstruction procedures, when selected by the operating surgeon.
Practical Considerations
- The device is selected and positioned according to the graft, bone tunnel, patient anatomy, and surgical technique.
- The button and polyester tape must be handled according to the manufacturer’s instructions for use.
- Available sizes and configurations should be confirmed in the current product labeling; the provided FDA record does not specify the complete size range.
- MRI safety depends on the exact device configuration and current manufacturer labeling. Confirm MR Safe, MR Conditional, or other status before scanning.
- Potential contraindications and complications include infection, poor bone quality, graft or fixation failure, malposition, and reactions to implant materials; the full labeling should be reviewed before use.
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.