About the Device

When a bone fractures, the body produces naturally occurring electric fields surrounding and within the fractured bone segments to stimulate repair.   These naturally occurring internal electrical fields are a critical biological process necessary for bone to grow and heal normally.

The purpose in using a bone growth stimulator is to mimic the body’s own natural occurring signaling processes by the application of an external, electric treatment signal for patients who may be at a higher risk of not healing.

The OrthoPak Stimulator System is a non-invasive, nonsurgical, medical device. The OrthoPak Stimulator utilizes a unique capacitive coupling technology that is designed to deliver a therapeutic, electrical treatment signal via a pair of disposable electrodes. The Soft-Touch® electrodes that accompany the system are lightweight and easily applied to the skin at the fracture nonunion site. The treatment signal operates at a low level frequency in which most patients don’t feel anything during treatment; however, some patients have reported feeling a slight, tingling sensation.

• The OrthoPak Stimulator System is easy to use, portable and battery operated.
• It’s the smallest and lightest non-invasive bone growth stimulator on the market allowing patients to treat while going about their daily routine.¹
• The Soft-Touch^® electrodes means less weight placed at the fracture nonunion site
• Compliance monitoring consistently tracks your treatment progress.
• Over 85,000 patients have been treated with the OrthoPak Stimulator System. ²
• The OrthoPak Stimulator System is FDA approved and has more than 30 years of clinical use in improving patients’ lives.³

The OrthoPak Stimulator System works by sending low level electrical impulses directly to the nonunion fracture site via a pair of disposable electrodes. Two lightweight electrodes are placed on either side of the fracture nonunion site and positioned 180 degrees apart from each other. The stimulator produces an electrical treatment signal in the area between the electrodes, which helps to mimic your body’s natural healing process.

The Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System is designed to deliver 270 days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours. Basic safety precautions should always be followed, including removal of the device prior to showering, bathing or swimming.

Healing outcomes may vary due to health, activity, risk factors or other medical conditions you may have.   Not all patients are candidates for this medical device so it’s important to speak with your doctor. Only a qualified health care professional can determine the appropriate treatment for each patient.

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 been established.

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.