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acufex arthroscopic shoulder guide system
Acufex Microsurgical
Summary: The Acufex Arthroscopic Shoulder Guide System is a surgical tool used in arthroscopic shoulder procedures, primarily by orthopedic surgeons. It aids in precise instrument placement during minimally invasive surgeries.
FDA Clearance Information
Pathway
510K
Number
K940481 ↗
Decision Date
May 6, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Arthroscopic Shoulder Guide System was cleared through the FDA 510k pathway on May 6, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Arthroscopic Shoulder Guide System is a specialized surgical instrument designed to assist in arthroscopic procedures of the shoulder. It facilitates the accurate placement of surgical instruments and implants through small incisions, enhancing the precision and efficiency of minimally invasive surgeries. This system is particularly useful in procedures such as rotator cuff repairs and labral repairs.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in arthroscopic shoulder procedures. It is utilized in both hospital and outpatient surgical settings. The system is designed for use in adult patients requiring shoulder surgery, such as those with rotator cuff tears or shoulder instability. Orthopedic surgeons rely on this system to improve surgical outcomes and reduce recovery times.
Indications for Use
The FDA indications for the Acufex Arthroscopic Shoulder Guide System include its use in facilitating arthroscopic shoulder surgeries. It is intended for patients undergoing minimally invasive procedures to address shoulder conditions like rotator cuff injuries.
Practical Considerations
The Acufex Arthroscopic Shoulder Guide System is designed to be compatible with standard arthroscopic equipment. Surgeons should be familiar with its setup and operation to ensure optimal performance. Proper sizing and alignment are crucial for effective use, and training in arthroscopic techniques is recommended.
Frequently Asked Questions
What is the Acufex Arthroscopic Shoulder Guide System used for?
It is used to assist in arthroscopic shoulder surgeries, facilitating precise instrument placement.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder procedures commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in arthroscopic shoulder surgeries to aid in instrument placement.
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.