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
510K
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.
Clinical Applications
This device is commonly used in orthopedic surgeries such as knee arthroscopy or total knee replacement. It is utilized in hospital operating rooms and ambulatory surgical centers. The primary users are orthopedic surgeons who require stable leg positioning to perform precise surgical interventions.
Indications for Use
The FDA indications suggest that the device is intended for use in surgical procedures requiring leg stabilization. It is suitable for patients undergoing orthopedic surgeries, particularly those involving the knee.
Practical Considerations
The Acufex Universal Leg Holder typically comes with adjustable straps and supports to accommodate various leg sizes. It is compatible with standard operating room tables. Clinicians should ensure proper positioning to avoid pressure points or nerve compression.
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.