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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 ?
510(k)
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.
FDA-Cleared Indications
- Measuring intra-articular distances during orthopedic surgical procedures.
Clinical Applications
- Measuring distances within the knee joint during surgery.
- Supporting intraoperative measurement during anterior cruciate ligament reconstruction.
- Assessing intra-articular anatomy during ligament repair or reconstruction procedures.
Practical Considerations
- The device is intended for use by trained orthopedic surgical personnel in an operating room or ambulatory surgical setting.
- Use should follow the manufacturer’s instructions for handling, measurement technique, cleaning, sterilization, and any required calibration or inspection.
- Compatibility with an orthopedic instrument set, surgical approach, and intended joint should be confirmed before the procedure.
- This is a surgical measuring instrument, not an implant or an MRI-compatible therapeutic device; MRI safety depends on the device’s material and manufacturer labeling.
- Contraindications, reusable-device processing requirements, and product-specific size information should be verified in the current manufacturer’s instructions for use.
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.