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acufex cannulated bone tunnel plugs
Cufex Microsurgical
Summary: The Acufex Cannulated Bone Tunnel Plugs are used in orthopedic surgeries, particularly for securing grafts in procedures like ACL reconstruction. They are typically used by orthopedic surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K925437 ↗
Decision Date
December 24, 1992
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Cannulated Bone Tunnel Plugs were cleared through the FDA 510(k) pathway on December 24, 1992. Manufactured by Cufex Microsurgical, this device is classified as Class 2 under product code HRX.
What It Is
The Acufex Cannulated Bone Tunnel Plugs are surgical devices designed to assist in the fixation of bone grafts during orthopedic procedures, such as anterior cruciate ligament (ACL) reconstruction. These plugs are used to secure grafts within bone tunnels, providing stability and promoting proper healing. Their cannulated design allows for precise placement and fixation using guide wires.
Clinical Applications
These plugs are commonly used in orthopedic surgeries, particularly in sports medicine for procedures like ACL reconstruction. They are typically utilized in hospital operating rooms by orthopedic surgeons. The device is suitable for patients undergoing ligament repair or reconstruction, often athletes or individuals with knee injuries.
Indications for Use
The FDA indications suggest that the Acufex Cannulated Bone Tunnel Plugs are intended for use in procedures requiring secure fixation of bone grafts, such as ligament reconstructions. This is particularly relevant for patients with knee ligament injuries, like ACL tears.
Practical Considerations
The plugs are available in various sizes to accommodate different patient anatomies and surgical needs. They are compatible with standard surgical instruments used in orthopedic procedures. Surgeons should be familiar with the technique for inserting and securing these plugs to ensure optimal outcomes.
Related Literature
The linked study compared the fixation strength of two ACL reconstruction techniques using bone-patellar tendon-bone grafts. The study found that the one-incision technique, which utilized Acufex instruments, provided significantly stronger graft fixation than the two-incision technique. However, the study was limited by its use of cadaveric knees, which may not fully replicate live surgical conditions.
Frequently Asked Questions
What is Acufex Cannulated Bone Tunnel Plugs used for?
They are used for securing bone grafts in orthopedic surgeries, such as ACL reconstruction.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine and knee surgeries.
What are the FDA-cleared indications?
The device is indicated for use in securing bone grafts during procedures like ligament reconstructions, especially in knee injuries.
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.