đź“‹ FDA Reference
Acufex Arthroscopic Suture Cutter
Acufex Microsurgical
Summary: The Acufex Arthroscopic Suture Cutter is a surgical tool used primarily by orthopedic surgeons for cutting sutures during arthroscopic procedures. It is designed for precision and ease of use in minimally invasive surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940506 ↗
Decision Date ?
April 26, 1994
Product Code ?
HRX
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Arthroscopic Suture Cutter was cleared via the FDA 510(k) pathway on April 26, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Arthroscopic Suture Cutter is a specialized surgical instrument designed for cutting sutures during arthroscopic procedures. It features a small, precise cutting mechanism that allows surgeons to easily and accurately cut sutures within the joint space. This device is particularly useful in minimally invasive surgeries where access is limited and precision is crucial.
FDA-Cleared Indications
- For cutting sutures during arthroscopic surgical procedures.
- For use in minimally invasive orthopedic procedures when controlled suture cutting is required.
Clinical Applications
- Cutting sutures during arthroscopic shoulder procedures.
- Cutting sutures during arthroscopic knee procedures.
- Managing sutures during arthroscopic meniscus repair procedures.
- Managing sutures during arthroscopic rotator cuff repair procedures.
- Cutting sutures in other arthroscopic joint procedures when required by the surgical technique.
Practical Considerations
- The instrument is intended for use through an arthroscopic working portal under direct arthroscopic visualization.
- The specific jaw configuration, shaft length, and working diameter should match the arthroscope, cannula, and surgical approach being used.
- The surgeon should confirm that the cutter is compatible with the suture material and intended for the planned cutting task.
- Use requires training in arthroscopic instrument handling to avoid damage to cartilage, tendons, nerves, vessels, or other joint structures.
- The available FDA record does not establish MRI safety; do not place the instrument in the MRI environment unless current manufacturer labeling confirms its status.
Frequently Asked Questions
What is the Acufex Arthroscopic Suture Cutter used for?
It is used for cutting sutures during arthroscopic procedures, particularly in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons and sports medicine specialists commonly use this device in joint surgeries.
What are the FDA-cleared indications?
It is indicated for use in arthroscopic procedures requiring suture management, such as minimally invasive joint surgeries.
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.