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acufex sub-acromial space measuring device
Acufex Microsurgical
Summary: The Acufex Sub-Acromial Space Measuring Device is used to measure the sub-acromial space during shoulder arthroscopy. It is primarily utilized by orthopedic surgeons to ensure accurate assessment and treatment of shoulder impingement.
FDA Clearance Information
Pathway
510K
Number
K940480 ↗
Decision Date
March 23, 1994
Product Code
HTJ
Device Class
Class 1
Evidence
0 studies
The Acufex Sub-Acromial Space Measuring Device was cleared through the FDA 510(k) pathway on March 23, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 1 device under product code HTJ.
What It Is
The Acufex Sub-Acromial Space Measuring Device is a surgical tool designed to measure the space beneath the acromion in the shoulder joint. This measurement is crucial during arthroscopic procedures to assess and treat shoulder impingement syndrome. The device provides precise measurements that help surgeons make informed decisions about the need for decompression or other interventions.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in procedures involving shoulder arthroscopy. It is essential for evaluating patients with suspected shoulder impingement, rotator cuff tears, or other sub-acromial pathologies. The device aids in determining the appropriate surgical approach and is typically used in hospital or ambulatory surgical center settings.
Indications for Use
The FDA indications suggest that this device is intended for use in measuring the sub-acromial space during shoulder arthroscopy. It is particularly useful for patients with shoulder pain or dysfunction suspected to be due to impingement or other sub-acromial issues.
Practical Considerations
The device is typically compatible with standard arthroscopic equipment and should be used by trained orthopedic surgeons. Proper technique involves careful insertion and measurement to avoid damage to surrounding tissues. The device's design allows for easy integration into the surgical workflow.
Frequently Asked Questions
What is the Acufex Sub-Acromial Space Measuring Device used for?
It is used to measure the sub-acromial space during shoulder arthroscopy, aiding in the assessment and treatment of shoulder impingement.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder arthroscopy commonly use this device.
What are the FDA-cleared indications?
The device is indicated for measuring the sub-acromial space during shoulder arthroscopy, particularly in cases of suspected impingement.
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.