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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 ?
510(k)
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.
FDA-Cleared Indications
- Fixation of soft-tissue grafts to bone during ligament reconstruction.
- Use in reconstructive orthopedic procedures requiring interference-screw fixation of a graft.
- Use during ACL reconstruction when an absorbable interference screw is selected for graft fixation.
Clinical Applications
- Fixation of soft-tissue grafts during ACL reconstruction.
- Interference fixation of ligament-reconstruction grafts within a bone tunnel.
- Orthopedic ligament-reconstruction procedures performed in a hospital or outpatient surgical setting.
Practical Considerations
- The screw is available in multiple sizes; the surgeon selects the size based on the bone tunnel, graft, anatomy and fixation technique.
- It is inserted with orthopedic surgical instruments under direct visualization and according to the product-specific surgical technique.
- The device is intended to resorb over time, but the rate and completeness of resorption depend on the material, implant site and patient factors.
- MRI safety should be confirmed in the current FDA labeling and manufacturer instructions before scanning; do not assume that an absorbable implant is automatically MR safe.
- Potential concerns include malposition, graft fixation failure, inflammatory or foreign-body reaction, breakage and infection. Contraindications and warnings should be reviewed in the current labeling.
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.