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 ?
510(k)
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.
FDA-Cleared Indications
- Fixation of soft-tissue grafts to bone during ligament reconstruction procedures.
- Use in procedures requiring stabilization of a ligament reconstruction graft within a bone tunnel, such as ACL reconstruction.
Clinical Applications
- Fixation of a soft-tissue graft during anterior cruciate ligament reconstruction.
- Stabilization of ligament reconstruction grafts within prepared bone tunnels.
- Insertion of the interference screw with the accompanying screwdriver during orthopedic ligament surgery.
Practical Considerations
- The screw is available in multiple sizes; the surgeon selects the size and length based on the graft, bone tunnel, anatomy and surgical technique.
- Use requires a compatible screwdriver and familiarity with the device-specific insertion technique.
- The procedure is performed in an operating room or ambulatory surgical center, usually with regional or general anesthesia.
- MRI safety depends on the screw's material and the specific device labeling. The exact model and material should be confirmed before MRI.
- Contraindications and precautions include inadequate bone quality, infection at the operative site, inability to achieve appropriate graft placement, and any contraindication listed in the current manufacturer labeling.
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.