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 ?
510(k)
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.
FDA-Cleared Indications
- Use during surgical reconstruction of the anterior cruciate ligament.
- Use to assist fixation of an ACL graft with an interference screw.
Clinical Applications
- ACL reconstruction after a traumatic ACL tear.
- Guidance or support for interference-screw fixation of an ACL graft.
- Use in knee ligament surgery performed in a hospital or ambulatory surgery setting.
Practical Considerations
- The surgeon selects the sheath and interference-screw dimensions based on the graft, bone tunnel, and patient anatomy.
- The device should be used only according to its labeling and the surgical technique provided by the manufacturer.
- Correct alignment and positioning are important to avoid graft or bone-tunnel damage and to achieve secure fixation.
- The FDA record identifies this as a Class II device cleared through the 510(k) pathway; the available record does not establish MRI safety.
- This instrument is intended for use by trained orthopedic surgical personnel and is not a stand-alone treatment for an ACL tear.
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.