Indications for Use, Contraindications, Warnings, and Precautions

OUS indication for use

The MID-C System is indicated for use in Patients with adolescent idiopathic scoliosis (AIS) having a single curve and classified as Lenke 1 (thoracic major curve) or Lenke 5 (thoracolumbar/lumbar major curve), having a Cobb angle of up to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from T5 to T12.

USA indication for use

The ApiFix MID-C System is indicated for use in patients with adolescent idiopathic scoliosis (AIS) for treatment of single curves classified as Lenke 1 (thoracic major curve) or Lenke 5 (thoracolumbar/lumbar major curve), having a Cobb angle of 35 to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from T5 to T12.Use of the MID-C System in patients with curves of lower magnitudes (i.e., less than 40 degrees) is based on the risk for curve progression.

Humanitarian Use Device

Authorized by Federal law for use in the treatment of adolescent idiopathic scoliosis (AIS).

The effectiveness of this device for this use has not been demonstrated.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Contraindications

The ApiFix MID-C System should not be implanted in patients meeting any of the following conditions:

• Any type of non-idiopathic scoliosis;¹
• Thoracic kyphosis in excess of 55 degrees measured between T5-T12;
• Any main thoracic deformity that includes vertebral levels including cranial to T2;
• Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site;
• Spinal cord abnormalities that require treatment;
• Presence of neurological deficit (defined as a motor grade of less than 5 out of 5); or
• Known poor bone quality defined as a T-score -1.5 or less.

Warnings

Metallic implants can loosen, fracture, corrode, migrate, or cause pain.

Precautions

• Safety and probable benefit of the ApiFix MID-C System in skeletally immature patients with a Risser Grade status less than or equal to 1 have not been established.
• The ApiFix MID-C System implants are supplied sterile and are for single use only and cannot be reused or re-sterilized.
• Do not use if the sterile package has been damaged or is open.
• Examine implant carefully prior to use to assure proper working condition. If you suspect a component to be faulty or damaged, do not use.
• Do not use this device without proper training.
• Patients implanted with the ApiFix MID-C System should not participate in contact or high demand sports such as weightlifting, tumbling, gymnastics, rowing, or other high- risk activities.
• Do not attempt to re-sterilize the ApiFix MID-C System Implantable components.
• Do not use if package is damaged or sterile barrier is broken.
• The surgeon should weigh the risks and benefits of using the ApiFix MID-C System in patients with the following conditions:
  • Insulin-dependent diabetes;
  • Cardiopulmonary or other systemic disease;
  • Bleeding disorder(s);
  • Ataxia;
  • Documented HIV or hepatitis infection;
  • Family history of neurofibromatosis or Marfan’s syndrome;
  • Medical contraindications to anesthesia;
  • Patients who have major psychiatric disorders, or a history of substance abuse. These conditions should be defined per standard criteria, such as the Diagnostic and Statistical Manual of Mental Disorders (DSM-V).

For potential risks associated with the ApiFix system and spinal surgery generally, please see the ApiFix system Instructions for Use.