Acufex Endobutton System

FDA-Cleared Indications

• Fixation of soft-tissue grafts during ACL reconstruction of the knee.

Clinical Applications

• Femoral-side fixation of a soft-tissue graft during arthroscopic ACL reconstruction.
• Securing a ligament graft in a bone tunnel until biological graft-to-bone healing occurs.
• Use with standard surgical techniques for ACL graft placement and fixation.

Reported off-label uses

• Similar cortical-button fixation techniques may be used for other ligament or tendon reconstructions, but these applications are not established here as FDA-cleared indications for the Acufex EndoButton System.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The system includes a fixation button and polyester tape; the selected size and configuration should match the graft, tunnel, and surgical technique.
• It is intended for use with orthopedic surgical and arthroscopic techniques by clinicians trained in graft fixation.
• The surgeon should confirm correct button deployment and seating against the cortical bone before completing fixation.
• The FDA record identifies the device as a Class II device under product code MAI; current labeling and instructions for use should be reviewed because product configurations and availability may change.
• MRI safety should not be assumed from the FDA clearance alone. The current device labeling should be checked for MRI conditions; the titanium component may be MR Conditional rather than universally MR Safe.