đź“‹ FDA Reference
acufex acl sheath for interference screws
Acufex Microsurgical
Summary: The Acufex ACL Sheath for Interference Screws is a surgical device used in orthopedic procedures, specifically for ACL reconstruction. It is typically utilized by orthopedic surgeons to secure grafts in knee surgeries.
FDA Clearance Information
Pathway
510K
Number
K940290 ↗
Decision Date
September 28, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex ACL Sheath for Interference Screws was cleared through the FDA 510(k) pathway on September 28, 1994. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex ACL Sheath for Interference Screws is a surgical tool designed to assist in the fixation of grafts during anterior cruciate ligament (ACL) reconstruction. It works by providing a stable interface for interference screws, which are used to secure the graft within the bone tunnel. This device is essential in ensuring proper alignment and stability of the graft, which is crucial for successful ACL repair.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in sports medicine, for ACL reconstruction. It is employed in both hospital and outpatient surgical settings. The primary patient population includes athletes and individuals with ACL injuries requiring surgical intervention. Orthopedic surgeons use this device to ensure the graft is securely fixed, promoting optimal healing and function.
Indications for Use
The FDA indications for this device involve its use in ACL reconstruction surgeries. It is specifically designed for patients who have sustained ACL injuries and require surgical intervention to restore knee stability and function.
Practical Considerations
The Acufex ACL Sheath is compatible with various sizes of interference screws, allowing for flexibility in surgical technique. Surgeons should consider the specific graft type and patient anatomy when selecting the appropriate sheath and screw size. Proper alignment and positioning are critical for optimal outcomes.
Related Literature
The linked study examined the failure strengths of different interference screw devices used in ACL reconstruction, comparing concentric and eccentric placements. The study found that the Intrafix device had a higher mean strength to failure compared to other devices tested. However, the study was limited by its use of animal models, which may not fully replicate human tissue properties.
Frequently Asked Questions
What is the Acufex ACL Sheath for Interference Screws used for?
It is used in ACL reconstruction surgeries to secure grafts within the knee joint.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine, use this device.
What are the FDA-cleared indications?
The device is indicated for use in ACL reconstruction surgeries to stabilize grafts in patients with ACL injuries.
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.