đź“‹ FDA Reference
Acufex Drez Communicating Drill Guide
Acufex Microsurgical
Summary: The Acufex Drez Communicating Drill Guide is a surgical tool used primarily in orthopedic procedures to assist in precise drilling. It is typically used by orthopedic surgeons in operating rooms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K834350 ↗
Decision Date ?
March 19, 1984
Product Code ?
FZX
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Drez Communicating Drill Guide was cleared via the FDA 510k pathway on March 19, 1984. Manufactured by Acufex Microsurgical, it is classified as a Class 1 device under product code FZX.
What It Is
The Acufex Drez Communicating Drill Guide is a specialized surgical instrument designed to facilitate accurate drilling during orthopedic procedures. It helps in aligning and guiding the drill to ensure precision, which is critical in surgeries involving bone fixation or reconstruction. The device is typically used in conjunction with other surgical tools to enhance the accuracy and safety of the procedure.
FDA-Cleared Indications
- For use as a drill guide during orthopedic surgical procedures requiring precise drilling.
- For guiding and aligning orthopedic drills during procedures involving bone or joint repair.
Clinical Applications
- Guiding drill placement during orthopedic bone procedures.
- Supporting accurate drilling during joint repair or reconstruction.
- Assisting with controlled drilling during ligament reconstruction procedures when specified by the surgical technique.
- Use in an operating room with compatible orthopedic drilling instruments.
Practical Considerations
- The device should be used by trained orthopedic surgical personnel according to the applicable surgical technique and manufacturer instructions.
- Confirm that the drill guide is properly aligned, securely positioned, and compatible with the orthopedic drill and accessories being used.
- The record identifies the device as a manual Class I instrument; it does not establish a specific size range or universal compatibility with all orthopedic drills.
- Clean, sterilize, inspect, and maintain the instrument according to the manufacturer's instructions before reuse, if designated as reusable.
- As a metallic surgical instrument, MRI safety should not be assumed. Check the current labeling and institutional MRI policy before bringing it into an MRI environment.
Frequently Asked Questions
What is the Acufex Drez Communicating Drill Guide used for?
It is used for precise drilling in orthopedic surgeries, such as joint or ligament reconstructions.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise drilling and alignment in orthopedic 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.