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acufex fixation post
Acufex Microsurgical
Summary: The Acufex Fixation Post is a medical device used primarily in orthopedic surgeries, particularly for ligament fixation. It is utilized by orthopedic surgeons to stabilize ligaments during reconstructive procedures.
FDA Clearance Information
Pathway
510K
Number
K924514 ↗
Decision Date
October 13, 1992
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Fixation Post was cleared through the FDA 510(k) pathway on October 13, 1992. It is manufactured by Acufex Microsurgical and is classified as a Class II medical device.
What It Is
The Acufex Fixation Post is a surgical instrument designed to assist in the fixation of ligaments during reconstructive procedures, such as anterior cruciate ligament (ACL) reconstruction. It provides a stable anchor point for sutures or grafts, ensuring proper alignment and tension. This device is particularly useful in orthopedic surgeries where precise ligament positioning is crucial for successful outcomes.
Clinical Applications
The Acufex Fixation Post is commonly used in orthopedic surgeries, especially in sports medicine for procedures like ACL reconstruction. It is typically employed in hospital operating rooms and outpatient surgical centers. The device is used by orthopedic surgeons to treat athletes and active individuals who have sustained ligament injuries, aiming to restore joint stability and function.
Indications for Use
The FDA-cleared indications for the Acufex Fixation Post involve its use in surgical procedures requiring ligament fixation. It is particularly indicated for patients undergoing reconstructive surgeries to repair torn ligaments, such as the ACL, to restore knee stability.
Practical Considerations
The Acufex Fixation Post is available in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with other fixation devices and techniques commonly used in ligament reconstruction. Surgeons should be familiar with the device's handling and placement to ensure optimal outcomes.
Related Literature
The linked study evaluated the outcomes of ACL reconstruction using the Acufex Endobutton and Suture Washer in 35 patients over a 2-3 year follow-up period. The study found that most patients achieved normal or nearly normal knee function, with satisfactory stability and high patient satisfaction scores. However, the study's limitations include its small sample size and lack of a control group, which may affect the generalizability of the findings.
Frequently Asked Questions
What is the Acufex Fixation Post used for?
The Acufex Fixation Post is used for ligament fixation during reconstructive surgeries, such as ACL reconstruction.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine and reconstructive surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring ligament fixation, such as ACL reconstruction, to restore joint stability.
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.