đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use for fixation of ligaments during orthopedic reconstructive procedures.
- Use as a fixation point for securing ligament grafts or sutures when restoring joint stability.
Clinical Applications
- Fixation of ligament grafts during anterior cruciate ligament reconstruction.
- Securing sutures or graft tissue during orthopedic ligament-repair procedures.
- Providing a stable fixation point during reconstructive surgery for traumatic ligament injury.
- Use in an operating room or ambulatory surgery center by a trained orthopedic surgeon.
Practical Considerations
- The surgeon selects the post size and fixation method according to the patient's anatomy, the ligament being reconstructed, and the surgical technique.
- Use must follow the device labeling and the manufacturer's surgical instructions, including appropriate placement and tightening.
- Compatibility with grafts, sutures, tunnels, screws, and other fixation components should be confirmed before surgery.
- The FDA record provided does not establish MRI safety; MRI conditions should be verified in the current labeling or directly with the manufacturer.
- Contraindications, sterilization requirements, and handling precautions should be reviewed in the current instructions for use.
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.