Product information on the Biomet® OrthoPak®
Non-invasive Bone Growth Stimulator
INDICATIONS: The Biomet® OrthoPak®
Non-invasive Bone Growth Stimulator System is FDA approved and
indicated for the treatment of an established nonunion acquired
secondary to trauma, excluding vertebrae and all flat bones, where the
width of the nonunion defect is less than one-half the width of the
bone to be treated.
USAGE: Federal Law (U.S.A.) restricts this device to sale by or
on the order of a physician. Rx Only - Prescription Only - Single
Patient Use Only - Not for Re-Sale or Re-Distribution - Do Not Reuse.
CONTRAINDICATIONS: The use of this device is contraindicated if
the individual has synovial pseudarthrosis.
WARNINGS: Animal safety studies indicate that the device does
not interfere with the normal intrinsic activity of the heart.
However, the stimulator does interfere with the operation of certain
pacemakers. The concomitant use of the device and a pacemaker must be
assessed on an individual basis, prior to use (such as with an electrocardiogram).
PRECAUTIONS: Although laboratory teratological studies
performed with this device demonstrate no adverse findings, the safety
of this device used during pregnancy and nursing in humans has not
Complete prescribing information including contraindications,
warnings and precautions associated with the use of this device may be
found online at www.LearnAboutBoneHealing.com
or by contacting customer service at 1-800-526-2579, extension 6000.
If you have additional questions regarding your doctor’s
instructions in using this device, or you are experiencing any type of
reaction with the use of this device, contact your doctor immediately.
For further product information, including warnings, refer to the
Patient Manual at www.LearnAboutBoneHealing.com,
or contact Customer Service at 1-800-526-2579, extension 6000.