ApiFix Procedure

Indications for Use

The ApiFix MID-C System is indicated for patients:

  • Having adolescent idiopathic scoliosis (AIS) classified as Lenke type 1 or Lenke type 5 having Cobb angle up to 60 degrees
  • Early onset scoliosis (EOS), above the age of 6 years old, having Cobb angle up to 75 degrees
  • Spinal deformity is flexible
  • Appropriate candidate for posterior surgical approach


The ApiFix System should not be implanted in patients meeting any of the following:

  • Any type of scoliosis not specified in the Indications for Use
  • Thoracic kyphosis >55 degrees measured between T5-T12 in AIS
  • Any main thoracic deformity that includes vertebral levels including and cranial to T2 in AIS
  • Known history of existing malignancy, or any systemic or local infection
  • Spinal cord abnormalities that require treatment
  • Presence of neurological deficit (defined as: motor grades 0-4, sensory grades 0-2, reflexes grade 0 or 4 or asymmetry of deep tendon reflexes >2 from right to left)
  • The need to either excise bony elements (hemivertebra, bony bar) or spinal fusion features, or any other bone removal that may result in mechanical instability that may compromise the function of the ApiFix System
  • Grossly distorted anatomy caused by congenital abnormalities
  • Known infection or pathologic conditions of bone such as osteopenia, severe bone resorption or osteomalacia, which would impair the ability to securely fix the device
  • Known metal allergies and sensitivities
  • Patient with pacemaker
  • Patients weighing less than 25 lb. (11.4 kg) or morbidly obese
  • Pregnancy
  • Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery
  • Any case where the implant components selected for use would be too large or too small to achieve a successful result
  • Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
  • Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
  • Any patient who is unwilling to follow postoperative instructions

Warnings and Precautions

  • The ApiFix System implants are supplied sterile and are for single use only; not to be reused or re-sterilized
  • The safety of the ApiFix System has not been established when re-used. Reuse of a single-use device can cause cross-contamination leading to patient infection
  • Do not use if the sterile package has been damaged or is opened
  • Examine implant carefully prior to use to assure proper working conditions. Do not us if you suspect a component to be faulty or damaged
  • Metallic implants can loosen, fracture, corrode, migrate, or cause pain
  • The implantation of the ApiFix System should be performed by a trained scoliosis surgeon
  • The MID-C XLP should not be used in patients above the age of 10
  • Patients implanted with the ApiFix System should not participate in contact or severe sports such as weightlifting, tumbling, gymnastics, rowing, or other high-risk activities

The surgeon should consider the risks and benefits of using the ApiFix System in patients with the following conditions:

  • Insulin-dependent diabetes;
  • Cardiopulmonary or other systemic diseases;
  • Bleeding disorder(s);
  • Ataxia;
  • Documented HIV or hepatitis infection;
  • Family history of neurofibromatosis or Marfan 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)
  • Fever or leukocytosis at a level unacceptable by the surgeon

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

MRI Safety Information

The ApiFix System is made of 100% Titanium Alloy per ASTM F-136 and is MR compatible.