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acufex fixation button retention bar wedge
Acufex Microsurgical
Summary: The Acufex Fixation Button Retention Bar Wedge is a surgical device used primarily in procedures involving soft tissue fixation. It is commonly utilized by orthopedic surgeons in settings such as hospitals and surgical centers.
FDA Clearance Information
Pathway
510K
Number
K896310 ↗
Decision Date
November 20, 1989
Product Code
KGS
Device Class
Class 1
Evidence
0 studies
The Acufex Fixation Button Retention Bar Wedge was cleared through the FDA's 510(k) pathway on November 20, 1989. It is manufactured by Acufex Microsurgical and classified as a Class 1 device under product code KGS.
What It Is
The Acufex Fixation Button Retention Bar Wedge is a surgical tool designed to assist in the secure fixation of soft tissues, particularly in orthopedic procedures. It functions by providing a stable anchor point for sutures or other fixation materials, ensuring that tissues remain in the desired position during healing. This device is particularly useful in procedures where precise tissue alignment is critical.
Clinical Applications
This device is commonly used in orthopedic surgeries, such as ligament repair or reconstruction, where secure tissue fixation is necessary. It is particularly relevant in sports medicine and trauma surgery, where maintaining the correct anatomical position of tissues is crucial for recovery. The device is typically employed in hospital operating rooms or specialized surgical centers.
Indications for Use
The Acufex Fixation Button Retention Bar Wedge is indicated for use in surgical procedures requiring the fixation of soft tissues. It is suitable for patients undergoing ligament repair or similar procedures where tissue stability is essential.
Practical Considerations
The device is available in various sizes to accommodate different surgical needs and anatomical variations. It is compatible with standard surgical instruments and techniques used in soft tissue fixation. Clinicians should ensure proper sizing and placement to optimize surgical outcomes.
Frequently Asked Questions
What is the Acufex Fixation Button Retention Bar Wedge used for?
It is used for soft tissue fixation in surgical procedures, particularly in orthopedic surgeries such as ligament repair.
What specialties typically use this device?
Orthopedic surgeons, especially those specializing in sports medicine and trauma surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring the fixation of soft tissues, such as ligament repair.
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.