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acufex rotator cuff fixation button
Acufex Microsurgical
Summary: The Acufex Rotator Cuff Fixation Button is a surgical device used for the fixation of rotator cuff tears. It is primarily used by orthopedic surgeons in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K941740 ↗
Decision Date
June 30, 1995
Product Code
KGS
Device Class
Class 1
Evidence
0 studies
The Acufex Rotator Cuff Fixation Button was cleared through the FDA 510(k) pathway on June 30, 1995. It is manufactured by Acufex Microsurgical and is classified as a Class 1 device.
What It Is
The Acufex Rotator Cuff Fixation Button is a medical device designed to assist in the surgical repair of rotator cuff injuries. It functions by providing secure fixation of the torn tendon to the bone, facilitating proper healing. The device is typically used in minimally invasive arthroscopic procedures, offering a reliable solution for rotator cuff stabilization.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in the repair of rotator cuff tears. It is utilized in both hospital and outpatient surgical settings, catering to patients with shoulder injuries, often due to sports or degenerative conditions. The device is essential for ensuring tendon-to-bone healing, which is crucial for restoring shoulder function.
Indications for Use
The FDA indications suggest the device is intended for patients with rotator cuff tears requiring surgical intervention. It is suitable for individuals experiencing shoulder pain and dysfunction due to tendon detachment.
Practical Considerations
The Acufex Rotator Cuff Fixation Button is available in various sizes to accommodate different patient anatomies. It is compatible with standard arthroscopic equipment, and surgeons should be familiar with the specific technique for optimal placement and fixation.
Frequently Asked Questions
What is the Acufex Rotator Cuff Fixation Button used for?
It is used for the surgical repair of rotator cuff tears, providing secure fixation of the tendon to the bone.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder surgeries commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with rotator cuff tears requiring surgical repair to restore shoulder function.
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.