Acufex Suretac

FDA-Cleared Indications

• Fixation of soft tissue to bone during arthroscopic surgery.
• Use in orthopedic procedures requiring fixation of soft tissue where the device is indicated by its FDA-cleared labeling.

Clinical Applications

• Arthroscopic fixation of soft tissue during shoulder stabilization surgery.
• Fixation of the detached labrum to the glenoid during an arthroscopic Bankart repair, when consistent with the device labeling.
• Fixation of labral tissue during arthroscopic treatment of a SLAP lesion, when consistent with the device labeling.

Reported off-label uses

• Use in selected arthroscopic soft-tissue fixation procedures outside the shoulder has been described for bioabsorbable fixation devices, but use depends on the specific product labeling, anatomy and surgeon judgment.

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 device is bioabsorbable, so it is intended to provide temporary fixation while tissue healing occurs rather than remain permanently as a metal implant.
• Available sizes, inserter compatibility and fixation strength depend on the specific Suretac model and the original surgical kit; clinicians should verify the product labeling and inventory.
• Placement is performed under arthroscopic visualization, typically through small portals, with the device seated in bone to secure the repaired soft tissue.
• MRI considerations depend on the exact material and model. The implant record and current manufacturer labeling should be checked before MRI; do not assume MRI conditions without documentation.
• Potential complications include fixation failure, recurrent instability, inflammatory or foreign-body reactions, cartilage or bone injury, infection and complications related to arthroscopic surgery.