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Acufex Sub-Acromial Space Measuring Device
Acufex Microsurgical
Summary: The Acufex Sub-Acromial Space Measuring Device is used to measure the sub-acromial space during shoulder arthroscopy. It is primarily utilized by orthopedic surgeons to ensure accurate assessment and treatment of shoulder impingement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940480 ↗
Decision Date ?
March 23, 1994
Product Code ?
HTJ
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Sub-Acromial Space Measuring Device was cleared through the FDA 510(k) pathway on March 23, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 1 device under product code HTJ.
What It Is
The Acufex Sub-Acromial Space Measuring Device is a surgical tool designed to measure the space beneath the acromion in the shoulder joint. This measurement is crucial during arthroscopic procedures to assess and treat shoulder impingement syndrome. The device provides precise measurements that help surgeons make informed decisions about the need for decompression or other interventions.
FDA-Cleared Indications
- Measuring the sub-acromial space during shoulder arthroscopy.
Clinical Applications
- Intraoperative measurement of the space beneath the acromion during arthroscopic shoulder procedures.
- Assessment of sub-acromial anatomy when planning or performing arthroscopic treatment.
- Use by trained surgical personnel in a hospital or ambulatory surgery setting.
Practical Considerations
- This is a manual surgical measuring instrument, not an implant or therapeutic device.
- It should be inserted and manipulated under arthroscopic visualization to reduce the risk of injury to surrounding tissues.
- Compatibility with arthroscopic cannulas and other equipment should be confirmed before the procedure.
- The FDA record does not provide MRI-safety information; because the device is used during surgery rather than left in the patient, MRI compatibility is generally not the primary clinical consideration.
- The instrument should be cleaned, sterilized, inspected and maintained according to the manufacturer's instructions. Reuse and service requirements depend on the specific device labeling.
Frequently Asked Questions
What is the Acufex Sub-Acromial Space Measuring Device used for?
It is used to measure the sub-acromial space during shoulder arthroscopy, aiding in the assessment and treatment of shoulder impingement.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder arthroscopy commonly use this device.
What are the FDA-cleared indications?
The device is indicated for measuring the sub-acromial space during shoulder arthroscopy, particularly in cases of suspected impingement.
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.