📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Fixation of soft tissue during orthopedic surgical procedures.
- Use in procedures requiring secure retention and stabilization of repaired or reconstructed soft tissue.
Clinical Applications
- Soft-tissue fixation during ligament repair.
- Soft-tissue fixation during ligament reconstruction.
- Retention of sutures or other fixation materials during orthopedic surgery.
- Stabilization of repaired tissue while healing occurs.
Practical Considerations
- The appropriate device size and configuration should be selected for the patient's anatomy and the planned fixation technique.
- Use requires appropriate surgical instruments, preparation, and placement by a qualified surgical team.
- The available FDA record does not establish MRI safety; MRI compatibility should be confirmed from current manufacturer labeling before scanning.
- Potential contraindications, including infection, inadequate tissue quality, or inability to achieve secure fixation, should be assessed by the treating surgeon.
- The device is intended for surgical use and should be handled according to the applicable manufacturer instructions and sterile-technique requirements.
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.