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acufex r arthroplasty instruments
Acufex Microsurgical
Summary: The Acufex R Arthroplasty Instruments are surgical tools used primarily in orthopedic procedures, particularly arthroplasty. These instruments are utilized by orthopedic surgeons to facilitate joint surgeries.
FDA Clearance Information
Pathway
510K
Number
K940985 ↗
Decision Date
May 16, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex R Arthroplasty Instruments were cleared through the FDA 510(k) pathway on May 16, 1994. Manufactured by Acufex Microsurgical, this Class 2 device is categorized under product code HRX.
What It Is
The Acufex R Arthroplasty Instruments are a set of precision surgical tools designed for use in joint replacement surgeries. These instruments aid in the accurate alignment and fixation of prosthetic components during arthroplasty. They are crafted to enhance surgical precision and improve patient outcomes by ensuring proper joint function post-surgery.
Clinical Applications
These instruments are commonly used in orthopedic operating rooms during procedures such as knee and hip replacements. They are essential in ensuring the correct placement of implants, which is crucial for the longevity and functionality of the prosthetic joint. The primary users are orthopedic surgeons who specialize in joint reconstruction and replacement surgeries.
Indications for Use
The FDA indications suggest that these instruments are intended for use in surgical procedures involving joint reconstruction, particularly in cases where joint function needs to be restored or improved. They are suitable for patients undergoing arthroplasty due to conditions like osteoarthritis or joint degeneration.
Practical Considerations
The Acufex R Arthroplasty Instruments are available in various sizes to accommodate different patient anatomies and surgical techniques. They are compatible with standard surgical protocols and are designed for ease of use in the operating room. Proper handling and sterilization are essential to maintain their precision and longevity.
Frequently Asked Questions
What is Acufex R Arthroplasty Instruments used for?
They are used for joint replacement surgeries, aiding in the precise placement of prosthetic components.
What specialties typically use this device?
Orthopedic surgeons specializing in joint reconstruction and replacement surgeries typically use these instruments.
What are the FDA-cleared indications?
The instruments are indicated for use in surgical procedures involving joint reconstruction, such as arthroplasty for osteoarthritis or joint degeneration.
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.