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 signaling 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® 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

Important Product Information

Product information on the Biomet® EBI® Bone Healing System

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.

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 PN1068243-00 at www.LearnAboutBoneHealing.com, or contact Customer Service at 1-800-526-2579, extension 6000.

Getting Started

The Bone Healing System Components

The following components are included:

  • Controller
  • AC Wall Adapter
  • 28 and Zero Inch Link Cables 
  • Clip Holder
  • Belt
  • SFLX Treatment Coil (Provided Separately) 

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.

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