About the Device

Electrical Spine Fusion Stimulation

Electrical stimulation of the spine is the application of an external treatment signal that helps promote the body’s own natural healing process following a spinal fusion.  A spine fusion stimulator is sometimes used to help the body heal; especially if specific risk factors or an underlying medical condition exists that may compromise normal healing.

The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System

Following a lumbar spine fusion surgery, your doctor may prescribe the SpinalPak Stimulator System which is a non-invasive, nonsurgical, medical device. The SpinalPak 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 on either side of the fusion 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 SpinalPak Stimulator System is easy to use, portable and battery operated.
  • The device is a small, lightweight non-invasive spinal fusion stimulator which allows patients to treat while going about their daily routine.
  • The Soft-Touch® electrodes can be comfortably worn under a brace. 
  • Compliance monitoring consistently tracks your treatment progress.
  • Nearly 490,000 patients have been treated with the SpinalPak Stimulator System.1
  • The SpinalPak Stimulator System is FDA approved and has more than 30 years of clinical use.2

Important Product Information

Product information on the Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System

INDICATIONS: The Biomet ® SpinalPak ® Non-invasive Spine Fusion Stimulator System is an FDA approved non-invasive spine fusion stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels - P850022/S017.

USAGE: The SpinalPak Non-invasive Spine Fusion 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: There are no known contraindications regarding the use of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System.

WARNINGS: The concomitant use of the device and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use. The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active Biomet SpinalPak Non-invasive Spine Fusion Stimulator System device. If there are any observable adverse changes in the pacemaker rhythm or output, the device should not be used.

The safety and effectiveness of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System in pregnant women have not been studied, and the effects of the device on the mother or the developing fetus are unknown. A patient who is either pregnant or is intending to become pregnant should be referred to her doctor prior to treatment with the device.

PRECAUTIONS: The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System has not been studied in individuals with the following conditions: spondylitis, infection, Paget’s disease, cancer, diabetes mellitus, renal disease, trauma of the lumbar spine and osteoporosis: therefore, the safety and effectiveness of the device in these individuals is unknown.

Complete prescribing information including 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.

However, 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 PN1067796-00 at Bone Healing, or contact Customer Service at 1-800-526-2579, extension 6000.

Getting Started

The SpinalPak 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

Spine Anatomy and Spinal Fusion

Spine Anatomy

The series of vertebrae which are separated by intervertebral discs is called the vertebral column. The vertebral column has four main functions within the body: to protect, support, provide stabilization, and movement. The vertebral column provides protection by enclosing the spinal cord within the spinal canal. It provides support by carrying the weight of the body above the pelvis. The vertebral column also provides stabilization by acting as the central axis of the body, which enables both posture and movement.

Regions of the Vertebral Column

The vertebral column may be categorized into regions. These regions are often referred to as cervical, thoracic, lumbar, sacrum, and coccyx. Some surgeons refer to the spinal column in these 5 regions, and others combine the sacrum and coccyx into a fourth region, by referring to it as the sacral region.

The cervical spine which is positioned at the top of the spine is located between the skull and the thoracic spine and is comprised of 7 vertebrae. These vertebrae may be labeled C1 to C7 starting at the very top of the cervical spine and working down toward the thoracic spine. The thoracic spine which is positioned between the cervical and lumbar spine is comprised of 12 vertebrae. These vertebrae may be labeled T1 to T12 starting at the very top of the thoracic spine and working down toward the lumbar spine. The lumbar spine which is positioned between the thoracic spine and the sacrum is comprised of 5 vertebrae. These vertebrae may be labeled L1-L5 starting at the very top of the lumbar spine and working down toward the sacrum. The sacrum is comprised of five naturally fused vertebrae and connects the lumbar spine to the coccyx. The coccyx pertains to the lowest vertebrae in the body positioned below the sacrum. The coccyx is commonly referred to as the “tail bone.”

Spinal Fusion

A spinal fusion is surgery performed to join two or more vertebrae into one single structure. The goal is to stop movement, create stability between the vertebrae and prevent back pain.

Your physician may recommend spinal fusion if no other treatment options have alleviated your back pain, or if you have an injury or certain medical condition, such as: degenerative disc disease, spondylolisthesis, spinal stenosis, scoliosis, spinal fractures and/or spinal tumors. There are several types of spinal fusion procedures and/or techniques available based on your individual circumstances.  All of this, including risks and benefits, should be discussed with a qualified healthcare professional in order for you to make an informed decision regarding treatment options, and whether spinal fusion is right for you.

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