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Acufex Fixation Button
Acufex Microsurgical
Summary: The Acufex Fixation Button is a surgical device used primarily in ligament reconstruction. Key evidence highlights its application in anterior cruciate ligament (ACL) surgeries with various fixation techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K884565 ↗
Decision Date ?
February 27, 1989
Product Code ?
KGS
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Fixation Button was cleared by the FDA via the 510(k) pathway on February 27, 1989. It is manufactured by Acufex Microsurgical and classified as a Class 1 device.
What It Is
The Acufex Fixation Button is a surgical fixation device designed for use in ligament reconstruction procedures. It provides secure fixation of soft tissue grafts to bone, commonly used in ACL reconstruction surgeries.
FDA-Cleared Indications
- Fixation of soft-tissue grafts to bone during ligament reconstruction procedures.
- Use in orthopedic ligament-reconstruction surgery when a fixation button is selected for graft attachment.
Clinical Applications
- Fixation of tendon or other soft-tissue grafts during anterior cruciate ligament reconstruction.
- Attachment of a ligament-reconstruction graft to bone through a drilled bone tunnel.
- Use during orthopedic reconstruction of a ligament requiring secure graft fixation.
Evidence Summary
The literature includes four studies ranging from 1995 to 2008, encompassing various study designs such as RCTs and case series. These studies focus on the efficacy and safety of the Acufex Fixation Button in ligament reconstruction.
Reported Outcomes
Published studies report that the Acufex Fixation Button is effective in securing grafts during ACL reconstruction, with techniques like the Endobutton fixation showing favorable outcomes in terms of graft stability and healing. The device is adaptable to various graft materials, enhancing its versatility in surgical applications.
Safety Profile
Reported complications include potential graft-tunnel motion, which can affect the kinematics of reconstructed ligaments. However, the Endobutton technique is noted for avoiding pitfalls associated with interference screw fixation, reducing the risk of additional incisions.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale RCTs. Further research is needed to compare long-term outcomes and safety profiles with alternative fixation methods.
Practical Considerations
- The appropriate button size and configuration depend on the graft, bone tunnel, fixation technique, and surgeon preference.
- Compatibility with the graft, tunnel dimensions, insertion instruments, and any additional fixation should be confirmed before use.
- The device is intended for use by trained orthopedic surgical personnel under appropriate surgical and imaging guidance.
- MRI safety depends on the device material and the specific labeling for the implanted product; do not assume that every fixation button is MRI safe or MRI conditional.
- Potential complications include loss of fixation, graft movement, tunnel widening, infection, pain, and the usual risks of ligament-reconstruction surgery.
Frequently Asked Questions
What are the clinical indications for Acufex Fixation Button?
The Acufex Fixation Button is indicated for use in ligament reconstruction surgeries, particularly for anterior cruciate ligament (ACL) repair.
What outcomes have been reported in clinical studies?
Studies report effective graft fixation and stability in ACL reconstruction, with favorable outcomes using the Endobutton technique.
What complications have been reported?
Safety data indicate potential graft-tunnel motion, but the Endobutton technique reduces risks associated with interference screw fixation.
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.