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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
510K
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.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly those involving joint repair and reconstruction, such as anterior cruciate ligament (ACL) surgery. It is utilized in hospital operating rooms and outpatient surgical centers. The primary users are orthopedic surgeons who require precise anatomical guidance to improve surgical outcomes and reduce recovery times for patients.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in procedures requiring precise anatomical guidance, such as surgeries to repair or reconstruct ligaments. It is particularly useful in cases where accurate alignment and placement of surgical instruments are critical.
Practical Considerations
The Acufex Director Anatomic Guide System is typically compatible with a range of surgical instruments used in orthopedic procedures. Surgeons should be familiar with its setup and calibration to ensure optimal performance. It is important to verify compatibility with existing surgical tools and to follow manufacturer guidelines for use.
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.