OrthoPediatrics’ implants are manufactured from well-established and recognized orthopedic materials with an extensive history of safe use, including but not limited to: 316L stainless steel, Biodur 108, Ti-6Al-4V, and cobalt chrome alloys. Testing has demonstrated the force exerted on the implants by the magnetic field in commercial MR machines is approximately 25% of the force due to gravity*. This indicates the mass of the implants is greater than the force from the machine, thus movement during an MRI scan is not expected. Additional safety is provided since most OrthoPediatrics implants are affixed to bone with screws or other fixation methods.
OrthoPediatrics has not received complaints of patient discomfort due to RF heating of implants to date. Devices at risk for significant temperature rise are those with small diameters and high aspect ratios when the length of the device is aligned in the bore of the MRI machine. For devices without MR conditions stated on the label, internal testing is being performed and IFUs will be updated when revised labeling has been cleared by appropriate regulatory bodies.
For more information regarding MR safety, please contact firstname.lastname@example.org