đź“‹ FDA Reference
Acufex Universal Leg Holder
Acufex Microsurgical
Summary: The Acufex Universal Leg Holder is a medical device used to stabilize a patient's leg during surgical procedures. It is primarily used by orthopedic surgeons in operating rooms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K830707 ↗
Decision Date ?
May 2, 1983
Product Code ?
FWZ
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Universal Leg Holder was cleared through the FDA 510(k) pathway on May 2, 1983. Manufactured by Acufex Microsurgical, it is classified as a Class 1 device.
What It Is
The Acufex Universal Leg Holder is a surgical accessory designed to securely hold and position a patient's leg during procedures. It is typically used in orthopedic surgeries to ensure stability and precision. The device allows for adjustable positioning, which is crucial for accessing different areas of the leg during surgery.
FDA-Cleared Indications
- For stabilizing and positioning the leg during surgical procedures.
- For use as a surgical accessory in procedures requiring controlled support of the lower extremity.
Clinical Applications
- Leg stabilization during knee surgery.
- Leg positioning during knee arthroscopy.
- Leg support during orthopedic procedures performed on an operating-room table.
Practical Considerations
- The holder should be adjusted to the patient's leg size and secured without excessive pressure.
- Padding and careful positioning are important to reduce pressure points and the risk of nerve or soft-tissue compression.
- Confirm that the device is compatible with the operating-room table and any attached surgical equipment before use.
- The available FDA record does not establish MRI safety; do not bring the device into an MRI environment unless the current manufacturer labeling confirms its status.
- Inspect the holder, straps, supports, and attachment components before use and follow the manufacturer's cleaning, disinfection, and maintenance instructions.
Frequently Asked Questions
What is the Acufex Universal Leg Holder used for?
It is used to stabilize and position a patient's leg during orthopedic surgical procedures.
What specialties typically use this device?
Orthopedic surgeons primarily use this device during leg and knee surgeries.
What are the FDA-cleared indications?
The device is indicated for use in surgeries requiring leg stabilization, particularly in orthopedic procedures.
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.