đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- To assist with placement of femoral tunnels during ACL reconstruction.
Clinical Applications
- Femoral tunnel placement during surgical ACL reconstruction.
- Guiding tunnel positioning to support anatomical placement of an ACL graft.
- Use during arthroscopic or open orthopedic knee surgery when femoral tunnel alignment is required.
Practical Considerations
- The device is intended for use by trained orthopedic surgical personnel familiar with ACL reconstruction and femoral tunnel-aiming techniques.
- Available sizes or configurations should be selected according to the patient's anatomy and the surgeon's operative technique.
- The aimer should be used with compatible ACL reconstruction instruments and processed according to the manufacturer's cleaning, sterilization, and handling instructions.
- This is a surgical instrument, not an implanted device; it is used in the operating room and is removed before the procedure is completed.
- MRI safety depends on the specific materials and whether any component is present in or near the scanner. Do not bring the instrument into the MRI environment unless its labeling confirms MRI compatibility.
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.