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acufex t-fix rotator cuff guide systems
Acufex Microsurgical
Summary: The Acufex T-Fix Rotator Cuff Guide Systems are surgical devices used primarily for arthroscopic procedures involving suture fixation. They are typically utilized by orthopedic surgeons in the treatment of rotator cuff injuries.
FDA Clearance Information
Pathway
510K
Number
K941364 ↗
Decision Date
May 16, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex T-Fix Rotator Cuff Guide Systems were cleared by the FDA through the 510(k) pathway on May 16, 1994. Manufactured by Acufex Microsurgical, this device is classified as a Class 2 medical device under product code HRX.
What It Is
The Acufex T-Fix Rotator Cuff Guide Systems are specialized surgical instruments designed to assist in the precise placement of sutures during arthroscopic procedures. These guides facilitate the repair of rotator cuff tears by allowing surgeons to accurately position sutures in the shoulder joint. The device is particularly useful in minimally invasive surgeries, offering enhanced visualization and access to the affected area.
Clinical Applications
These guide systems are commonly used in orthopedic surgeries, particularly in the repair of rotator cuff injuries. They are employed in both hospital and outpatient surgical settings, primarily by orthopedic surgeons. The device is suitable for use in a wide range of patients, including those with acute or chronic rotator cuff tears, and can be particularly beneficial in cases requiring precise suture placement.
Indications for Use
The FDA indications suggest that the device is intended for use in surgical procedures involving the fixation of soft tissues, such as the rotator cuff, to bone. It is designed for patients with rotator cuff injuries requiring surgical intervention.
Practical Considerations
The Acufex T-Fix Rotator Cuff Guide Systems are compatible with standard arthroscopic equipment and sutures. Surgeons should be familiar with arthroscopic techniques and the specific handling of the guide system to ensure optimal outcomes. Proper sizing and positioning are crucial for effective use.
Related Literature
The linked study evaluated the use of the Rotator Cuff Guide in the suture fixation of tibial eminence avulsion fractures. Conducted over a 12-year period, the study involved 17 patients and assessed outcomes such as pain and joint stability. The study found that the guide system facilitated effective suture placement, resulting in satisfactory clinical outcomes. However, the study's retrospective nature and small sample size are limitations.
Frequently Asked Questions
What is the Acufex T-Fix Rotator Cuff Guide Systems used for?
It is used for the precise placement of sutures during arthroscopic rotator cuff repair surgeries.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in arthroscopic shoulder surgeries.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures involving the fixation of soft tissues, such as the rotator cuff, to bone.
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.