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acufex r endo-femoral aimer
Acufex Microsurgical
Summary: The Acufex R Endo-Femoral Aimer is a surgical instrument used primarily in orthopedic procedures to assist in accurate femoral tunnel placement during ACL reconstruction. It is typically used by orthopedic surgeons in hospital or surgical center settings.
FDA Clearance Information
Pathway
510K
Number
K942846 ↗
Decision Date
September 28, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex R Endo-Femoral Aimer was cleared through the FDA 510(k) pathway on September 28, 1994. It is manufactured by Acufex Microsurgical and classified as a Class 2 device under product code HRX.
What It Is
The Acufex R Endo-Femoral Aimer is a precision surgical tool designed to aid in the accurate placement of femoral tunnels during anterior cruciate ligament (ACL) reconstruction surgeries. It provides surgeons with a reliable method to ensure the correct anatomical positioning of grafts, which is crucial for successful surgical outcomes. The device is typically made of durable materials suitable for repeated sterilization and use in a sterile surgical environment.
Clinical Applications
This device is primarily used in orthopedic surgery, specifically during ACL reconstruction procedures. It is utilized in settings such as hospitals and specialized surgical centers. The Acufex R Endo-Femoral Aimer is particularly beneficial for orthopedic surgeons aiming to achieve precise tunnel placement, which is essential for the stability and function of the reconstructed ligament. It is used in patients undergoing ACL repair, often athletes or individuals with knee injuries.
Indications for Use
The FDA-cleared indication for the Acufex R Endo-Femoral Aimer is to assist in the accurate placement of femoral tunnels during ACL reconstruction surgeries. This device is intended for patients requiring surgical intervention for ACL injuries, which can result from sports-related activities or trauma.
Practical Considerations
The Acufex R Endo-Femoral Aimer is available in various sizes to accommodate different patient anatomies and surgical techniques. It is compatible with standard surgical instruments used in ACL reconstruction. Surgeons should be familiar with the specific aiming technique required for optimal use of the device, ensuring precise tunnel placement.
Frequently Asked Questions
What is the Acufex R Endo-Femoral Aimer used for?
It is used to assist in the accurate placement of femoral tunnels during ACL reconstruction surgeries.
What specialties typically use this device?
Orthopedic surgeons specializing in sports medicine and knee surgeries typically use this device.
What are the FDA-cleared indications?
It is indicated for assisting in the placement of femoral tunnels during ACL 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.