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acufex arthroscope
Acufex Microsurgical
Summary: The Acufex Arthroscope is a surgical device used primarily for minimally invasive procedures. Key evidence highlights its use in arthroscopic suture fixation and shoulder instability repair.
FDA Clearance Information
Pathway
510K
Number
K843208 ↗
Decision Date
September 11, 1984
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Arthroscope was cleared through the FDA 510(k) pathway on September 11, 1984. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex Arthroscope is a medical device designed for arthroscopic procedures, allowing for minimally invasive surgery. It is used to visualize, diagnose, and treat joint conditions.
Clinical Applications
Commonly used in procedures such as arthroscopic suture fixation of tibial eminence fractures and Bankart repair for shoulder instability. It provides a less invasive option for joint surgeries.
Evidence Summary
The literature includes various study types such as retrospective and prospective studies, with a total of 10 studies reviewed. The studies span from 1997 to 2014.
Reported Outcomes
Published studies report successful outcomes in arthroscopic suture fixation of tibial eminence fractures and Bankart repair for shoulder instability. The device has been shown to simplify tissue fixation and improve surgical outcomes.
Safety Profile
Reported complications include pneumothorax from overpenetration during arthroscopic procedures. Careful technique is required to minimize risks associated with device use.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Acufex Arthroscope?
The device is indicated for use in arthroscopic procedures such as suture fixation of tibial eminence fractures and Bankart repair for shoulder instability.
What outcomes have been reported in clinical studies?
Studies have reported successful outcomes in joint stabilization and repair, with improved surgical efficiency and patient recovery.
What complications have been reported?
Safety data indicate risks such as pneumothorax due to overpenetration during procedures, highlighting the need for careful surgical technique.
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.