đź“‹ FDA Reference
Acufex Arthroscopic Shoulder Guide System
Acufex Microsurgical
Summary: The Acufex Arthroscopic Shoulder Guide System is a surgical tool used in arthroscopic shoulder procedures, primarily by orthopedic surgeons. It aids in precise instrument placement during minimally invasive surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940481 ↗
Decision Date ?
May 6, 1994
Product Code ?
HRX
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Arthroscopic Shoulder Guide System was cleared through the FDA 510k pathway on May 6, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Arthroscopic Shoulder Guide System is a specialized surgical instrument designed to assist in arthroscopic procedures of the shoulder. It facilitates the accurate placement of surgical instruments and implants through small incisions, enhancing the precision and efficiency of minimally invasive surgeries. This system is particularly useful in procedures such as rotator cuff repairs and labral repairs.
FDA-Cleared Indications
- Used to facilitate arthroscopic surgical procedures of the shoulder.
- Intended to assist with accurate placement of surgical instruments during minimally invasive shoulder surgery.
Clinical Applications
- Arthroscopic shoulder procedures requiring guided placement of surgical instruments.
- Arthroscopic treatment of shoulder conditions when the surgeon needs a guide for instrument positioning.
- Use in hospital or ambulatory surgery settings by trained orthopedic surgical personnel.
Practical Considerations
- The system should be used by clinicians trained in arthroscopic shoulder surgery and familiar with the specific instrument configuration.
- Proper guide size, alignment and positioning are important for accurate instrument placement and to avoid injury to surrounding structures.
- Compatibility with arthroscopes, cannulas and other surgical instruments should be confirmed before the procedure.
- The FDA record provided does not establish MRI safety; the device should be treated as not evaluated for MRI unless current manufacturer labeling confirms its MR status.
- Cleaning, sterilization, inspection and reuse must follow the current manufacturer instructions. The record provided does not specify a single-use or reusable configuration.
Frequently Asked Questions
What is the Acufex Arthroscopic Shoulder Guide System used for?
It is used to assist in arthroscopic shoulder surgeries, facilitating precise instrument placement.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder procedures commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in arthroscopic shoulder surgeries to aid in instrument placement.
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.