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acufex endofix absorbable interference screw
Acufex Microsurgical
Summary: The Acufex Endofix Absorbable Interference Screw is used in orthopedic surgeries, particularly for securing soft-tissue grafts in ACL reconstructions. It is typically used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K954246 ↗
Decision Date
February 15, 1996
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Endofix Absorbable Interference Screw was cleared via the FDA 510(k) pathway on February 15, 1996. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex Endofix Absorbable Interference Screw is a biodegradable device used to secure soft-tissue grafts to bone during reconstructive surgeries, such as anterior cruciate ligament (ACL) repairs. Made from materials that gradually dissolve in the body, it eliminates the need for a second surgery to remove the hardware. This screw provides stable fixation, allowing for proper graft integration and healing.
Clinical Applications
Commonly used in orthopedic procedures, the Acufex Endofix is particularly valuable in ACL reconstruction surgeries. It is used by orthopedic surgeons in both hospital and outpatient surgical settings. The device is suitable for patients undergoing ligament repair, especially those who may benefit from absorbable fixation to avoid long-term implant complications.
Indications for Use
The FDA-cleared indications suggest that this device is used for securing grafts in ligament reconstruction surgeries. It is particularly indicated for patients undergoing ACL repair, where stable fixation of the graft is crucial for successful outcomes.
Practical Considerations
The Acufex Endofix comes in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard surgical instruments used in ACL reconstruction. Surgeons should be familiar with the technique of inserting absorbable screws to ensure optimal placement and fixation.
Related Literature
The linked study compared the motion of ACL replacement grafts fixed with either a titanium button and polyester tape or a biodegradable interference screw like the Acufex Endofix. It found that the type of fixation can affect graft-tunnel motion and knee kinematics. While the study provides insights into fixation methods, it is limited by its focus on a specific surgical scenario and may not cover all potential clinical outcomes.
Frequently Asked Questions
What is Acufex Endofix Absorbable Interference Screw used for?
It is used to secure soft-tissue grafts to bone during reconstructive surgeries, such as ACL repairs.
What specialties typically use this device?
Orthopedic surgeons commonly use this device in reconstructive ligament surgeries.
What are the FDA-cleared indications?
The device is indicated for use in securing grafts during ligament reconstruction surgeries, such as ACL 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.