Acufex Tag Anchor

FDA-Cleared Indications

• Attachment of soft tissue to bone during orthopedic surgery.
• Use as a non-metallic suture anchor for securing soft-tissue structures where bone fixation is required.

Clinical Applications

• Fixation of soft tissue to bone in hand surgery.
• Attachment of tendons or other soft-tissue structures to bone during orthopedic procedures.
• Use in orthopedic repairs requiring suture-anchor fixation.

Reported off-label uses

• Rotator cuff repair and other shoulder soft-tissue repairs have been described for suture anchors of this device type, but the specific cleared labeling should be confirmed before use.

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 anchor is non-metallic; confirm the exact material and MRI conditions in the current device labeling before MRI.
• Select the anchor and suture configuration appropriate for the tissue, bone quality, repair site, and required fixation strength.
• Use requires compatible insertion instruments and preparation of the bone according to the manufacturer's instructions.
• Avoid use when bone quality, infection, soft-tissue condition, or other factors are unlikely to support secure fixation.
• The device is intended for trained surgical use; current labeling and availability should be verified because the FDA clearance dates to 1995.