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acufex sterile cannulated interference screw
Acufex Microsurgical
Summary: The Acufex Sterile Cannulated Interference Screw is a medical device used primarily in orthopedic procedures to secure grafts in ligament reconstruction surgeries. It is typically used by orthopedic surgeons in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K900132 ↗
Decision Date
March 28, 1990
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Sterile Cannulated Interference Screw was cleared through the FDA 510(k) pathway on March 28, 1990. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex Sterile Cannulated Interference Screw is designed to provide secure fixation of soft tissue grafts in bone tunnels during ligament reconstruction surgeries, such as ACL repairs. The screw is cannulated, allowing it to be placed over a guide wire for precise positioning. Its sterile packaging ensures it is ready for immediate use in the operating room.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in sports medicine for anterior cruciate ligament (ACL) reconstruction. It is utilized in hospital operating rooms and outpatient surgical centers. The primary patient population includes athletes and individuals with ligament injuries requiring surgical intervention.
Indications for Use
The FDA indications suggest its use for securing grafts in ligament reconstruction surgeries. It is suitable for patients undergoing procedures like ACL repair, where stable fixation of the graft is crucial for successful outcomes.
Practical Considerations
The Acufex Sterile Cannulated Interference Screw comes in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard surgical instruments and techniques used in ligament reconstruction. Surgeons should select the appropriate size based on the specific procedure and patient anatomy.
Frequently Asked Questions
What is the Acufex Sterile Cannulated Interference Screw used for?
It is used to secure grafts in ligament reconstruction surgeries, such as ACL repairs.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in securing grafts during ligament reconstruction surgeries, such as ACL repairs.
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.