Stainless Steel Orthopaedic Cable System

FDA-Cleared Indications

• Fixation and stabilization of bone fragments during orthopaedic surgery
• Encircling and compressing bone fragments to maintain alignment during healing

Clinical Applications

• Fixation of selected fractures, including fractures around a joint replacement
• Stabilization of femoral fracture fragments
• Cerclage fixation during orthopaedic reconstruction
• Securing repaired tendon or bone-tendon tissue when specified by the device labeling

Reported off-label uses

• Adjunctive fixation in selected osteotomies
• Supplemental fixation during revision arthroplasty

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 cable must be selected in a size and configuration appropriate for the bone, fracture pattern and fixation technique.
• It is intended for use with compatible orthopaedic instruments and implants; compatibility should be confirmed before surgery.
• The cable should be handled according to the manufacturer’s instructions to avoid kinking, fraying or damage that could reduce fixation strength.
• Because it is stainless steel, MRI conditions should be confirmed from the specific device labeling and implant configuration before scanning.
• Contraindications and precautions may include active infection, inadequate bone quality, metal sensitivity and inability to follow postoperative restrictions.