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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
510K
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.
Clinical Applications
The device is frequently used in orthopedic surgeries, particularly for anterior cruciate ligament (ACL) reconstruction. It is suitable for athletes and individuals requiring ligament repair due to sports injuries or trauma.
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.
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.