About the Device

Electrical Bone Growth Stimulation

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

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 have specific risk factors or an underlying medical condition that may compromise normal healing.

The Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System

The OrthoPak Stimulator System is a non-invasive, nonsurgical, medical device. The OrthoPak Stimulator System 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.
  • The device is a small, light-weight non-invasive bone growth stimulator which allows patients to treat while going about their daily routine.
  • The Soft-Touch® electrodes means less weight placed at the fracture nonunion site. 
  • Compliance monitoring consistently tracks your treatment progress.
  • Over 100,000 patients have been treated with the OrthoPak Stimulator System.1
  • The OrthoPak Stimulator System is FDA approved and has more than 30 years of clinical use.2

Important Product Information

Product information on the Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System

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. A nonunion is considered to be established when there are no visibly progressive signs of healing - P850022/S017. 

USAGE: The OrthoPak 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. 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: Utilization of this stimulator allows full weight bearing on the casted extremity unless gross motion (greater than 5 degrees in any plane) at the nonunion site is present. In such a case, weight bearing is not advised and should not be permitted as this may compromise the effectiveness of the treatment. The safety and effectiveness of the use of the device on individuals lacking skeletal maturity has not been established. 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 Bone Healing, 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 PN1067800-00 at Bone Healing, or contact Customer Service at 1-800-526-2579, extension 6000.

Getting Started

The OrthoPak Stimulator System Components

The following components are included:

  • Controller
  • Two Rechargeable Battery Packs
  • Charging Cradle 
  • AC Wall Adapter
  • 20 and 48 Inch Lead Wires
  • Soft-Touch® Electrodes
  • Electrode Cover Patches 
  • Device Holster

Fracture Healing and Fracture Nonunion

Fracture Healing

Bone, like other tissues within the human body, are capable of healing when injured or damaged. When a fracture occurs, the body produces naturally occurring electric fields that generate high metabolic activity surrounding and within the bone that help to heal the fracture.  Occasionally, the fracture may not heal normally. This impaired ability to heal may result in what is called a fracture nonunion.

There are a number of underlying medical conditions and risk factors that may affect normal bone healing and result in a fracture nonunion. These include, but may not be limited to: chronic drug use, smoking, diabetes, obesity, chronic obstructive pulmonary disease (COPD), osteoporosis, renal disease, cancer, osteomyelitis (i.e., infection), rheumatoid arthritis, hypertension, etc.

Fracture Nonunion

A fracture nonunion is considered to be established when there are no visibly progressive signs of healing. Typically, bone starts to heal after a fracture occurs or after a surgeon has re-aligned, reduced and/or set the fractured bone fragments back into alignment.

During the following weeks or months, new bone tissue forms and continues to grow. As long as the fractured bone fragments receive an adequate supply of blood and other bio-chemical induced nutrients, newly formed bone tissue will grow and fuse together into a solid remodeled, repaired bone. The majority of bone fractures heal normally.

A fracture nonunion is a serious medical complication and may occur when bone lacks adequate stability, weight bearing control, blood flow, or when there are other underlying medical conditions which impair normal healing.3

Customer Service Information

If you have additional questions about the device, Zimmer Biomet Customer Service Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday at 1-800-526-2579 extension 6000. At other times, please leave a clear message for a return call by the next business day.

Customer service can assist with:

  • Answering product related questions

  • Placing orders for additional supplies, such as electrodes 

  • Reporting an adverse event or product complaint