đź“‹ FDA Reference
Acufex Director Application Anatomic Guide System
Smith & Nephew Inc., Endoscopy Div.
Summary: The Acufex Director Anatomic Guide System is a medical device used primarily in orthopedic procedures to assist in precise surgical navigation. It is typically used by orthopedic surgeons in hospital or surgical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111843 ↗
Decision Date ?
November 14, 2011
Product Code ?
OLO
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Director Anatomic Guide System was cleared through the FDA 510(k) pathway on November 14, 2011. It is manufactured by Smith & Nephew Inc., Endoscopy Division, and is classified as a Class 2 device under product code OLO.
What It Is
The Acufex Director Anatomic Guide System is a surgical tool designed to aid in the accurate placement of instruments during orthopedic procedures. It functions as a guide for ensuring anatomical precision, which is crucial in surgeries such as ACL reconstructions. The device is part of a suite of tools that enhance the surgeon's ability to perform minimally invasive procedures with greater accuracy.
FDA-Cleared Indications
- Use as an anatomic guide during orthopedic surgical procedures that require accurate positioning of surgical instruments.
- Use in ligament repair or reconstruction procedures, including procedures involving the knee.
Clinical Applications
- Anatomic guidance during anterior cruciate ligament reconstruction.
- Guidance for positioning instruments during orthopedic ligament repair or reconstruction.
- Use in minimally invasive orthopedic procedures requiring accurate alignment and placement of instruments.
- Use in hospital operating rooms or outpatient surgical centers by trained orthopedic surgical teams.
Practical Considerations
- The system should be used only by trained surgical professionals according to the manufacturer's instructions for use.
- Confirm compatibility with the specific surgical instruments, implants and arthroscopic equipment used for the procedure.
- Inspect the guide before use and follow the manufacturer's cleaning, sterilization, handling and maintenance instructions.
- The available guide configuration and size must match the patient's anatomy and the planned orthopedic procedure.
- MRI safety cannot be determined from the available FDA record; do not bring the device into an MRI environment unless its specific labeling confirms that it is MR Safe or MR Conditional.
Frequently Asked Questions
What is the Acufex Director Anatomic Guide System used for?
It is used to provide precise anatomical guidance during orthopedic surgeries, such as ACL reconstructions.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring anatomical guidance, particularly in ligament repair and 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.