đź“‹ FDA Reference
Acufex Arthroscopic Shaver
Acufex Microsurgical
Summary: The Acufex Arthroscopic Shaver is a surgical tool used primarily in minimally invasive procedures to remove tissue. It is commonly used by orthopedic surgeons during arthroscopic surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844130 ↗
Decision Date ?
March 21, 1985
Product Code ?
HSZ
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Arthroscopic Shaver was cleared through the FDA 510(k) pathway on March 21, 1985. It is manufactured by Acufex Microsurgical and is classified as a Class 1 device under product code HSZ.
What It Is
The Acufex Arthroscopic Shaver is a precision surgical instrument designed for use in arthroscopic procedures. It consists of a motorized handpiece with interchangeable blades that allow for the resection of soft tissue and bone. This device enhances the surgeon's ability to perform minimally invasive surgeries by providing efficient tissue removal and debridement.
FDA-Cleared Indications
- Removal or resection of soft tissue during arthroscopic procedures.
- Removal or resection of bone during arthroscopic procedures.
- Use with arthroscopic equipment for surgical debridement and tissue removal.
Clinical Applications
- Arthroscopic removal of torn or damaged tissue in the knee.
- Arthroscopic removal of torn or damaged tissue in the shoulder.
- Meniscectomy, or removal of part or all of a damaged meniscus.
- Synovectomy, or removal of inflamed joint-lining tissue.
- Removal of loose bodies from a joint.
- Arthroscopic debridement of soft tissue or bone.
Practical Considerations
- The system uses interchangeable blades or cutting attachments, with sizes and configurations selected for the target tissue and joint.
- It is used with compatible arthroscopic visualization, irrigation, suction and motor-control equipment; compatibility should be confirmed before the procedure.
- The surgeon must maintain direct arthroscopic visualization and use controlled blade movement to limit injury to surrounding cartilage, nerves, vessels and other tissues.
- The device is not inherently MRI-safe; the handpiece, blades and accessories should be removed from the MRI environment unless their labeling specifically permits MRI use.
- Contraindications and precautions depend on the planned arthroscopic procedure, the patient's condition and the specific device labeling.
Frequently Asked Questions
What is the Acufex Arthroscopic Shaver used for?
It is used for the removal of soft tissue and bone during arthroscopic surgeries, particularly in the knee and shoulder.
What specialties typically use this device?
Orthopedic surgeons and sports medicine specialists commonly use this device in arthroscopic procedures.
What are the FDA-cleared indications?
It is indicated for use in arthroscopic procedures requiring tissue and bone removal, such as meniscectomies and synovectomies.
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.