đź“‹ FDA Reference
Acufex Interference Screw Sterile
Acufex Microsurgical
Summary: The Acufex Interference Screw Sterile is a surgical device used primarily in orthopedic procedures for securing grafts during ligament reconstruction. It is typically used by orthopedic surgeons in hospital or surgical center settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K895711 ↗
Decision Date ?
January 9, 1990
Product Code ?
HWC
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Interference Screw Sterile was cleared through the FDA 510k pathway on January 9, 1990, by Acufex Microsurgical. It is classified as a Class 2 device under product code HWC.
What It Is
The Acufex Interference Screw Sterile is a medical device used in orthopedic surgeries, particularly for securing soft tissue grafts to bone during procedures like anterior cruciate ligament (ACL) reconstruction. The screw is designed to provide stable fixation, allowing the graft to integrate with the bone. Made from biocompatible materials, it is available in various sizes to accommodate different patient anatomies.
FDA-Cleared Indications
- Fixation of grafts during ligament reconstruction procedures.
- Securing a soft-tissue or bone graft to bone to provide fixation during healing.
Clinical Applications
- Fixation of an autograft or allograft during ligament reconstruction.
- Femoral or tibial graft fixation during ACL reconstruction when compatible with the surgical technique.
- Graft fixation during other orthopedic ligament-reconstruction procedures covered by the device labeling.
Practical Considerations
- The surgeon must select the appropriate screw diameter and length for the graft, bone tunnel, anatomy, and fixation technique.
- The screw must be compatible with the graft material, tunnel dimensions, insertion instruments, and surgical system being used.
- Proper insertion technique is important to reduce the risk of graft damage, inadequate fixation, screw migration, or bone injury.
- The FDA record and supplied text do not establish MRI safety; MRI conditions should be confirmed from the current device labeling or manufacturer documentation before scanning.
- Contraindications, warnings, sterilization status, and handling requirements should be reviewed in the current instructions for use.
Frequently Asked Questions
What is Acufex Interference Screw Sterile used for?
It is used for securing grafts in ligament reconstruction surgeries, such as ACL repairs.
What specialties typically use this device?
Orthopedic surgeons and sports medicine specialists typically use this device.
What are the FDA-cleared indications?
It is indicated for use in securing grafts during ligament reconstruction 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.