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

Contraindications

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.

For Healthcare Professionals

For Patients and Families

ApiFix Procedure

About Us

Contact

Privacy Policy

Terms of Use

ApiFix Ltd.

1 Hacarmel Street
Kochav Yokneam Bldg.
Yokneam Illit 2069207
ISRAEL

OrthoPediatrics Corp.

2850 Frontier Drive
Warsaw, IN 46582
USA

T. 1-877-268-6339

ApiFix Ltd. is a wholly-owned subsidiary of OrthoPediatrics Corp. www.orthopediatrics.com

ApiFix, The Internal Brace Option, and Refuse to Fuse are trademarks of ApiFix Ltd. ApiFix is a registered trademark in the United States.

The ApiFix procedure is classified as a humanitarian use device authorized by U.S. federal law for use in the treatment of adolescent idiopathic scoliosis (AIS). The effectiveness of this device for this use has not been demonstrated. Federal law restricts this device to sale by or on the order of a physician.

Design and development by RainCastle Communications.

© 2021 ApiFix Ltd. All rights reserved.