đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use as surgical instruments during arthroplasty and joint reconstruction procedures.
- Intended to assist the surgeon with preparation, alignment, and placement of components during joint surgery.
- Use is limited to the procedures and techniques described in the device labeling and accompanying instructions.
Clinical Applications
- Instrument assistance during total or partial knee arthroplasty when included in the applicable surgical system and technique.
- Instrument assistance during hip arthroplasty when included in the applicable surgical system and technique.
- Bone preparation and alignment during joint reconstruction procedures.
- Use by orthopedic surgeons and operating-room staff following the manufacturer’s instructions for use.
Practical Considerations
- The available instruments may include different sizes and configurations for patient anatomy and the selected surgical technique.
- Compatibility with implants, cutting guides, trial components, power equipment, and other instruments should be confirmed before surgery.
- Reusable instruments require cleaning, inspection, maintenance, packaging, and sterilization according to the manufacturer’s instructions.
- The FDA record does not establish MRI safety for these instruments. MRI use should be avoided unless the specific instrument has documented MR labeling.
- Contraindications, warnings, and limitations should be taken from the current manufacturer labeling; the instruments themselves do not treat the underlying joint disease.
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.