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acufex interference screw sterile
Acufex Microsurgical
Summary: The Acufex Interference Screw Sterile is a surgical device used primarily in orthopedic procedures for securing grafts during ligament reconstruction. It is typically used by orthopedic surgeons in hospital or surgical center settings.
FDA Clearance Information
Pathway
510K
Number
K895711 ↗
Decision Date
January 9, 1990
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Interference Screw Sterile was cleared through the FDA 510k pathway on January 9, 1990, by Acufex Microsurgical. It is classified as a Class 2 device under product code HWC.
What It Is
The Acufex Interference Screw Sterile is a medical device used in orthopedic surgeries, particularly for securing soft tissue grafts to bone during procedures like anterior cruciate ligament (ACL) reconstruction. The screw is designed to provide stable fixation, allowing the graft to integrate with the bone. Made from biocompatible materials, it is available in various sizes to accommodate different patient anatomies.
Clinical Applications
This device is commonly used in orthopedic and sports medicine surgeries, especially for ligament repairs and reconstructions such as ACL surgery. It is typically used in hospital operating rooms or specialized surgical centers. The primary patient population includes athletes and individuals with ligament injuries requiring surgical intervention.
Indications for Use
The FDA indications suggest that this device is used for securing grafts in ligament reconstruction surgeries. It is suitable for patients undergoing procedures to repair or reconstruct torn ligaments, often due to sports injuries or trauma.
Practical Considerations
The Acufex Interference Screw Sterile comes in various sizes to fit different patient needs and surgical requirements. It is important to select the appropriate size for optimal fixation and to ensure compatibility with the surgical technique being employed. Surgeons should be familiar with the insertion technique to avoid complications.
Frequently Asked Questions
What is Acufex Interference Screw Sterile used for?
It is used for securing grafts in ligament reconstruction surgeries, such as ACL repairs.
What specialties typically use this device?
Orthopedic surgeons and sports medicine specialists typically use this device.
What are the FDA-cleared indications?
It is indicated for use in securing grafts during ligament reconstruction surgeries.
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.