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acufex shoulder holder
Acufex Microsurgical
Summary: The Acufex Shoulder Holder is a medical device used to stabilize the shoulder during surgical procedures. It is primarily used by orthopedic surgeons in operating rooms.
FDA Clearance Information
Pathway 510K
Number K841388 ↗
Decision Date May 16, 1984
Product Code HST
Device Class Class 1
Evidence 0 studies
The Acufex Shoulder Holder was cleared through the FDA 510(k) pathway on May 16, 1984, by Acufex Microsurgical. It is classified as a Class 1 device under product code HST.
What It Is
The Acufex Shoulder Holder is a surgical tool designed to stabilize the shoulder joint during arthroscopic and open shoulder surgeries. It helps maintain the desired position of the shoulder, allowing surgeons to perform procedures with greater precision and control. This device is particularly useful in surgeries that require immobilization of the shoulder to access the joint space effectively.
Clinical Applications
The Acufex Shoulder Holder is commonly used in orthopedic surgeries, particularly those involving the shoulder joint such as rotator cuff repairs, shoulder arthroscopy, and shoulder stabilization procedures. It is used in hospital operating rooms and ambulatory surgical centers, primarily by orthopedic surgeons. The device is suitable for a wide range of patients undergoing shoulder surgery, from athletes to elderly individuals with degenerative joint conditions.
Indications for Use
The FDA indications suggest that the Acufex Shoulder Holder is intended for use in procedures requiring shoulder stabilization. This includes surgeries where maintaining a fixed shoulder position is critical for surgical access and precision.
Practical Considerations
The Acufex Shoulder Holder typically comes in adjustable sizes to accommodate different patient anatomies. It is compatible with standard operating room tables and can be integrated into various surgical setups. Surgeons should ensure proper positioning and secure attachment to avoid intraoperative movement.
Frequently Asked Questions
What is the Acufex Shoulder Holder used for?
The Acufex Shoulder Holder is used to stabilize the shoulder during surgical procedures, allowing for precise surgical intervention.
What specialties typically use this device?
Orthopedic surgeons primarily use this device during shoulder surgeries.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring shoulder stabilization, such as arthroscopic and open shoulder surgeries.
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.