Products & Implants

Products & Implants


Songer® Spinal Cable System

Songer<sup>®</sup> Spinal Cable System 1

The Songer® Spinal Cable System is an innovative alternative to monofilament wire for spinal fixation procedures resulting from trauma, degenerative conditions and scoliosis. The system offers stainless steel or titanium cable that can be tensioned and secured using a single instrument. The Songer Spinal Cable is designed primarily for sublaminar passage.

Regulatory approvals vary by country. Therefore, we kindly ask you to contact the distributor in your region regarding availability of specific products, implants and / or instrumentation in your region.

Songer<sup>®</sup> Spinal Cable System 1


  • Cable

    • Simple insertion
    • Guides easily, reducing the chance of kinking
    • Provides superior strength over traditional monofilament wire*

    Instrumentation

    • Allows for reproducible tension
    • Tensioning and crimping can be achieved in one instrument
    • A known level of tension can be achieved using the Torque Driver

    * Technical data on file at RTI Surgical, Inc.

  • Implants are supplied sterile. Instruments are supplied nonsterile. For sterilization instructions, please reference the package insert.

  • Indications

    • GENERAL (Applies to both sternal and spinal applications)
      • Temporary implant to stabilize / secure bone fractures
      • Augment the process of bony fusions
      • Orthopedic trauma or reconstructive surgery
    • SPINAL INDICATIONS 
      • Spinal trauma surgery
      • Spinal reconstructive surgery
      • Spinal degenerative surgery
    • STERNAL INDICATIONS 
      • Cardiovascular sternal closure

    Intended Use

    RTI Surgical cable products were designed as a replacement for monofilament wire and may be used anywhere monofilament wire has previously been indicated.

    Contraindications

    Contraindications may include, but are not limited to:

    • Presence of documented infection;
    • Patient metal allergy or intolerance;
    • Presence of severe osteopenia and/or osteoporosis, rapid bone absorption, metabolic bone disease, cancer, tumor, or tumor like condition of the bone;
    • Inadequate tissue coverage of implant site;
    • Interference with other critical anatomical structures;
    • Undiagnosed infection, end stage malignant disease, or other unexplained disease;
    • Severely comminuted fractures;
    • Any patient unwilling to follow postoperative instructions; and
    • Any situation not defined by Indications.

    Warnings and Precautions

    • WARNING Do not intermix implants with different metallic alloy types.
    • WARNING Do not use if packaging is damaged / opened prior to use.
    • CAUTION Operating surgeon should have a good understanding of the cable system, surgical technique, and bio-mechanical principles of cable fixation.
    • CAUTION Federal law (USA) restricts the use of this device on the order of a physician only.
    • IMPORTANT Avoid over tensioning cables as they may break / fray.
    • IMPORTANT Cables may cut through soft bone that is not protected and immobilized.

    See product specific surgical technique manual and package insert for complete instructions and labeling limitations.

    Possible Adverse Effects 

    • Irritation or inflammation of soft tissue structures surrounding implant
    • Cables may cut through soft osteoporotic, osteopenic or cancellous bone if not properly protected and immobilized
    • Bone formation surrounding the implant (s) making removal difficult
    • Early fraying, kinking, loosening, or breaking of cable construct
    • Irritation from implant(s) where there is thin or inadequate soft tissue coverage over the implant 
    • Loss of spinal correction or loss of reduction of fractures or dislocations secondary to loosening, disassembly or breakage of the cables or secondary to cables cutting through osteoporotic bone
    • Infection
    • Foreign body reaction causing possible tumor-like condition
    • Nonunion or delayed union of bone fracture or bony fusion
    • Rare possible neurovascular compromise, disruption of blood circulation, and/or • vessel damage due to improper cable placement and/or improper assembly of the systems components
    • Cessation of growth of the operated portion of the bone

      NOTE: It may be necessary to perform additional surgery in order to correct some of the adverse effects or reactions that may or may not be related to the actual cable .system