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acufex intra articular measuring device
Acufex Microsurgical
Summary: The Acufex Intra Articular Measuring Device is a surgical instrument used primarily in orthopedic procedures to measure intra-articular distances. It is used by orthopedic surgeons during procedures such as ACL reconstructions.
FDA Clearance Information
Pathway
510K
Number
K925335 ↗
Decision Date
December 29, 1992
Product Code
HTJ
Device Class
Class 1
Evidence
0 studies
The Acufex Intra Articular Measuring Device was cleared through the FDA 510(k) pathway on December 29, 1992. It is manufactured by Acufex Microsurgical and is classified as a Class 1 device under product code HTJ.
What It Is
The Acufex Intra Articular Measuring Device is a precision instrument designed for use in orthopedic surgeries to measure distances within joints. It aids surgeons in accurately assessing anatomical structures during procedures, ensuring precise placement of grafts or implants. This device is particularly useful in surgeries requiring meticulous measurement, such as ligament reconstructions.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in procedures involving the knee, such as anterior cruciate ligament (ACL) reconstructions. It is utilized in hospital operating rooms and ambulatory surgical centers by orthopedic surgeons. The device is essential for ensuring accurate measurements in patients undergoing joint surgeries, contributing to successful surgical outcomes.
Indications for Use
The FDA indications suggest that this device is intended for use in measuring intra-articular distances during surgical procedures. It is particularly relevant for patients undergoing surgeries that require precise measurement within joints, such as ligament repairs or reconstructions.
Practical Considerations
The Acufex Intra Articular Measuring Device is typically compatible with standard orthopedic surgical kits. Surgeons should be familiar with its use to ensure accurate measurements. It is important to verify the device's calibration before use to maintain precision during surgery.
Related Literature
The linked study investigated the motion of an ACL replacement graft within the femoral bone tunnel when secured by different fixation methods. It compared EndoButton fixation with a biodegradable interference screw. The study found differences in graft-tunnel motion and evaluated the impact on knee kinematics and graft forces. However, the study's limitations include its focus on specific fixation methods and its applicability to broader clinical practices.
Frequently Asked Questions
What is the Acufex Intra Articular Measuring Device used for?
It is used for measuring intra-articular distances during orthopedic surgeries, particularly in procedures like ACL reconstructions.
What specialties typically use this device?
Orthopedic surgeons commonly use this device during joint surgeries, especially in knee-related procedures.
What are the FDA-cleared indications?
The device is indicated for use in measuring intra-articular distances during surgical procedures, aiding in precise anatomical assessments.
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.