đź“‹ FDA Reference
acufex interference screw and screwdriver
Acufex Microsurgical
Summary: The Acufex Interference Screw and Screwdriver is a surgical tool used primarily in orthopedic procedures to secure grafts in ligament reconstruction surgeries. It is typically used by orthopedic surgeons in hospital or surgical center settings.
FDA Clearance Information
Pathway
510K
Number
K883910 ↗
Decision Date
October 12, 1988
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Interference Screw and Screwdriver was cleared through the FDA 510(k) pathway on October 12, 1988. It is manufactured by Acufex Microsurgical and is classified as a Class 2 medical device.
What It Is
The Acufex Interference Screw is a surgical device designed to fixate soft tissue grafts to bone during ligament reconstruction surgeries, such as ACL repairs. The accompanying screwdriver is used to insert the screw into the bone, ensuring secure graft placement. This device is crucial in providing stability and promoting proper healing post-surgery.
Clinical Applications
Commonly used in orthopedic surgeries, the Acufex Interference Screw is integral in procedures like anterior cruciate ligament (ACL) reconstruction. It is used in hospital operating rooms and ambulatory surgical centers, primarily by orthopedic surgeons. The device is suitable for patients undergoing ligament repair, particularly athletes and active individuals.
Indications for Use
The FDA indications suggest that this device is used for securing grafts in ligament reconstruction surgeries. It is specifically indicated for patients requiring stabilization of soft tissue grafts to bone, such as those undergoing ACL repair.
Practical Considerations
The Acufex Interference Screw comes in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard surgical instruments and techniques used in ligament reconstruction. Surgeons should be familiar with the specific insertion technique to ensure optimal outcomes.
Frequently Asked Questions
What is the Acufex Interference Screw and Screwdriver used for?
It is used to secure soft tissue grafts to bone in ligament reconstruction surgeries, such as ACL repairs.
What specialties typically use this device?
Orthopedic surgeons typically use this device in hospital and surgical center settings.
What are the FDA-cleared indications?
The device is indicated for use in securing grafts during ligament reconstruction surgeries, particularly for stabilizing soft tissue grafts to bone.
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.