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acufex endobutton system
Acufex Microsurgical
Summary: The Acufex EndoButton System is a medical device used primarily in orthopedic surgeries, specifically for anterior cruciate ligament (ACL) reconstruction. It is utilized by orthopedic surgeons to secure soft-tissue grafts during knee surgeries.
FDA Clearance Information
Pathway
510K
Number
K933948 ↗
Decision Date
July 21, 1994
Product Code
MAI
Device Class
Class 2
Evidence
0 studies
The Acufex EndoButton System was cleared through the FDA 510(k) pathway on July 21, 1994. It is manufactured by Acufex Microsurgical and classified as a Class 2 device under product code MAI.
What It Is
The Acufex EndoButton System is a fixation device used in orthopedic procedures to secure soft-tissue grafts, particularly in ACL reconstruction surgeries. It functions by anchoring the graft to the bone using a titanium button and polyester tape, providing stability and support during the healing process. This system is designed to minimize graft-tunnel motion, which is crucial for successful surgical outcomes.
Clinical Applications
The device is commonly used in orthopedic settings, particularly in sports medicine and knee surgery. It is employed in procedures involving ACL reconstruction, where precise graft fixation is critical. The system is suitable for use in both outpatient and inpatient surgical settings, catering to athletes and active individuals requiring knee ligament repair.
Indications for Use
The FDA indications for the Acufex EndoButton System primarily focus on its use in securing soft-tissue grafts during ACL reconstruction. It is intended for patients undergoing knee ligament repair, particularly those with ACL injuries.
Practical Considerations
The Acufex EndoButton System is available in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard arthroscopic surgical techniques and instruments. Surgeons should be familiar with the device's insertion technique to ensure optimal graft fixation and patient outcomes.
Related Literature
The linked study investigated the motion of ACL replacement grafts within the femoral bone tunnel when secured with the EndoButton fixation compared to a biodegradable interference screw. The study found that the EndoButton system effectively minimized graft-tunnel motion, which is important for maintaining knee stability post-surgery. However, the study's limitations include its focus on biomechanical outcomes rather than long-term clinical results.
Frequently Asked Questions
What is the Acufex EndoButton System used for?
The Acufex EndoButton System is used for securing soft-tissue grafts during anterior cruciate ligament (ACL) reconstruction surgeries.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine and knee surgeries, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in securing soft-tissue grafts during ACL reconstruction, particularly for patients undergoing knee ligament 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.