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Biomet®  EBI®  Bone Healing System

Electrical Bone Growth Stimulation

OverviewAbout The DeviceGetting StartedFrequently Asked QuestionsResourcesContact Us

Overview

The Biomet® EBI® Bone Healing System

The Bone Healing System is a non-invasive, nonsurgical, medical device intended to treat a fracture nonunion, a failed fusion or congenital pseudarthrosis in the appendicular system.

  • The Bone Healing System has been designed so that it’s convenient to use, comfortable to wear and may be applied on the skin, over a brace, or cast.
  • It’s easy to operate and offers 12 flexible treatment coils to treat any fracture nonunion in the upper or lower extremities.
  • Over 700,000 patients have been treated with the Bone Healing System.1
  • The Bone Healing System is FDA approved and has more than 40 years of clinical use.2

Introducing the Biomet EBI Bone Healing System

Fracture and Fusion 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, fractured 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

  • Failed Fusion

    A failed fusion occurs when two or more bones within a joint (i.e., knee or ankle) have not fused together into a solid mass.  When this occurs it’s likely that you will experience pain, limb-length discrepancy and/or deformity because the joint lacks optimal skeletal support and stability. A failed fusion must be confirmed radiographically through a diagnostic X-ray or scanned via MRI by a qualified radiologist.

  • Congenital Pseudarthrosis

    Pseudoarthrosis is defined as a “false joint” or break in the bone that fails to heal on its own and usually develops within the first two years of life; however, there have been reported cases diagnosed before birth as well as later in life.  When pseudoarthrosis is diagnosed before or is present at birth, it’s referred to as congenital pseudarthrosis and can cause a variety of complications over time. The exact cause is unclear. Some believe that after the fracture occurs, there is a lack of blood supply to the outer layer of bone which promotes normal healing. This lack of blood supply results in scar tissue that forms and covers the bone which hinders proper healing.

    In most cases, surgical intervention is required to correct the pseudarthrosis; however, the affected bone is susceptible to re-fracture as this condition is challenging to treat. Due to the inherent difficulty involved, it’s likely that the healthcare professional will administer additional, adjunctive therapies to treat the pseudarthrosis in an attempt to promote healing.

About The Device

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.

  • How It Works

    The Bone Healing System works by sending pulsed electrical impulses from the controller to the treatment site via an external flexible treatment coil, which generates an electromagnetic field that surrounds the treatment site helping to mimic your body’s own natural healing process.  

  • Recommended Use

    The Bone Healing System is programmed to deliver a maximum of 270 therapeutic treatment periods. ZimVie recommends a therapeutic treatment period of 10 hours per day. A therapeutic treatment period is defined as a 10-hour treatment session accomplished either continuously or discontinuously in segments totaling 10 hours. Patients unable to treat on consecutive days will be able to treat non-consecutively within 400 days after the first one-hour treatment period. If the device is not used for a 12-hour period, the device’s treatment clock will automatically reset and be ready to deliver the next 10-hour therapeutic treatment period when next turned on.

    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.

  • Important Product Information

    INDICATIONS: The Biomet ® EBI ® Bone Healing System is indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system. A nonunion is considered to be established when there are no visibly progressive signs of healing – P790002/S028.

    USAGE: The recommended daily treatment dosage is normally 10 hours per day. The maximum recommended therapeutic treatment period is nine months (approximately 270 days). This device system is a durable therapeutic electrical device intended for single patient use only under a prescription. Federal Law (U.S.A.) restricts these devices 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: Nonunion fractures in which a synovial pseudarthrosis (fluid filled gap) exists. Under certain conditions, electromagnetic stimulation could inhibit or impair the functioning of certain external, non-invasive and/or implanted, invasive active medical devices inclusive of “all active electrical and non-active conductive/metallic implants”. Use of the Biomet EBI Bone Healing System on pregnant patients has not been evaluated; therefore, it is not recommended. MRI scans should not be performed on patients until the device system has been completely removed.

    WARNINGS: Use of the Biomet EBI Bone Healing System for the spine and skull have not been evaluated.

    PRECAUTIONS: Nonunion fractures with gaps in excess of 1.0 cm or the presence of fixation devices or instrumentation made from magnetic materials may compromise a successful treatment outcome.

Frequently Asked Questions

The Bone Healing System

  • How can I obtain a Bone Healing System?

    A qualified healthcare professional (HCP) must prescribe a Bone Healing System. The Bone Healing System is a non-invasive bone growth stimulator indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system. A nonunion is considered to be established when there are no visibly progressive signs of healing.

  • I have a pacemaker. Can I use the system?

    No. The use of a pacemaker or cardioverter with the Bone Healing System is contraindicated and not recommended.

  • My doctor prescribed a cam walking fracture boot, cast or wrist splint/brace. Can I use the Bone Healing system while wearing these?

    Yes, the treatment coil can be placed over or on top of a boot, cast or bracing. Once the coil has been shaped, center and apply the coil around the treatment site.

    An extremity band is an additional optional component that may be ordered through Customer Service. The extremity band allows the controller to be worn conveniently on the arm or leg.

  • Is the system MRI safe?

    MRI scans and procedures should not be performed until the Bone Healing System has been completely removed.

  • Is the system safe to use during pregnancy?

    Use of the Bone Healing Stimulator System during pregnancy has not been evaluated; therefore, it is not recommended.

  • Will insurance cover the cost of the device?

    Insurance coverage varies depending on your insurance plan. The Bone Healing System is generally recognized by Medicare, Medicaid, worker’s compensation as well as private and public health plans. HIGHRIDGE’s Patient Advocacy Group is available to assist you and discuss any questions regarding insurance coverage, deductibles and potential out-of-pocket expenses. 

  • Who do I contact if I have questions or need to order supplies?

    ZimVie’s Customer Care Representatives are ready to answer your questions.

  • Can I bring my bone stimulator on a plane when traveling?

    Yes, however, it’s important to follow and adhere to TSA guidelines which can be found at the following TSA websites:

    Link: Disabilities and Medical Conditions

    • Please select “External Medical Devices” from the drop-down menu under:
    • Please choose a situation to see more information.*

    Link: TSA Notification Card 

Important Product Information

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.

Resources

The Bone Healing System

The Biomet® EBI® Bone Healing System® Physician Manual

Download PDF

The Biomet® EBI® Bone Healing System® Patient Manual

Download PDF

Additional Information

Customer Service Information

If you have additional questions about the device, HIGHRIDGE Customer Service Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday at 1-800-377-5804.

Contact Us

Customer service can assist with:

  • Answering product related questions

  • Placing orders for additional supplies, such as electrodes

  • Reporting an adverse event or product complaint