- Data on file at Zimmer Biomet – ZBDATA1_20
- Data on file Zimmer Biomet – P850022
*The individuals depicted in the videos are actors.
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.
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 works by sending low level electrical impulses directly to the spine fusion site via a pair of lightweight, disposable electrodes. The electrodes are placed 2 to 3 inches on either side of the fusion sight. The stimulator produces an electrical treatment signal in the area between the electrodes, which helps to mimic your body’s natural healing process.
The SpinalPak 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 healthcare professional can determine the appropriate treatment for each patient.
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.
The following components are included:
To begin charging the first battery pack, connect the AC wall adapter to the charging cradle and plug the adapter into an outlet. The green indicator light is located on the AC Wall adaptor to indicate power. There are two LED lights at the top of the charging cradle which indicate the status of the battery pack. A solid orange light will appear when the battery pack is charging. When the orange light turns off, and a solid green light appears, the battery pack is fully charged.
Remove a pair of electrodes from its packaging. To connect the lead wires to the electrodes and controller, first insert the black lead wires into the corresponding white electrode lead wire connectors. Once the electrodes are connected, insert the lead wire plug into the opening at the top of the controller.
The electrodes are intended to be placed approximately 4 to 6 inches apart. Place one of the electrodes 2 to 3 inches on one side of the fusion site. Next, place the other electrode 2 to 3 inches on the other side of the fusion site. A small or slight misalignment in electrode placement is allowable. The exact placement of the electrodes should be left at the discretion of the prescribing physician.
Open the battery door on the back of the controller by pressing down on the battery door latch and then slide it down to remove it from the controller. Insert a fully charged battery pack into the controller by aligning the arrows on the battery pack with the corresponding arrows in the controller; then, insert it completely and slide the battery door back into place on the controller.
When the battery pack is inserted, the LED light on the top of the controller will blink, indicating the controller is operational. Inserting the battery pack automatically turns the controller on. Once a battery pack has been utilized for the full 24-hour treatment period it should be replaced.
The controller includes both an audible and visible self-checking alarm mechanism to signal and alert if the controller is not functioning properly. The button located below the controller’s display enables or disables the audible alarm. In the event the controller is beeping and needs to be silenced, press and hold the button below the display until the alarm is disabled. After silencing the alarm, the light will continue to flash and the display will indicate an alarm condition. The alarm should be enabled as a precaution to ensure the controller is always treating.
The controller will display the following symbols each time it is turned on and activated:
The blinking checkmark symbol indicates that the controller is treating;
The battery symbol indicates the amount of remaining battery life;
The speaker symbol indicates the audible alarm is enabled, which is the default for the audible alarm being active.
In addition to the symbols that appear on the controller’s display once turned on, there are also a variety of symbols that may appear during treatment. Please reference the Patient Manual included with your system assembly for detailed descriptions of each symbol.
Watch this short video to learn more about How to Operate the SpinalPak Stimulator System*
Included within each system assembly are lightweight Soft-Touch® electrodes. Each pair of electrodes are intended to be worn between one to seven days. To order additional electrodes, free of charge, call Zimmer Biomet’s Customer Service team at 1-800-526-2579, extension 6000.
The Soft-Touch® electrodes that accompany the SpinalPak Stimulator System are intended to be placed 2 to 3 inches on either side of the fusion site; 4 to 6 inches apart.
Click the image below to view a gallery of videos intended to provide proper electrode guidance placement for some of the most common lumbar spinal fusions.*
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.
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.”
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.
How can I obtain a SpinalPak Stimulator System?
A qualified healthcare professional (HCP) must prescribe a SpinalPak Stimulator System. The SpinalPak Stimulator System is a non-invasive spine fusion stimulator indicated for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
I have a pacemaker. Can I use the system?
The use of a pacemaker or cardioverter must be assessed on an individual basis. Zimmer Biomet recommends that you speak with a qualified healthcare professional. This may require consultation with a cardiologist, who can monitor your pacemaker with an electrocardiogram while the patient is wearing the SpinalPak Stimulator System.
My doctor prescribed a back brace. Can I use the system while wearing a back brace over my fusion site?
Yes, the SpinalPak Stimulator System’s electrodes can be worn comfortably underneath a back brace. Apply the electrodes directly to the skin, with each electrode positioned two to three inches on one side of the fusion site and the other electrode positioned two to three inches on the other side of the site. Once the electrodes are positioned, you can wear the back brace as directed by the healthcare professional.
Is the system MRI safe?
MRI scans and procedures should not be performed until the SpinalPak Stimulator System has been completely removed.
Is the system safe to use during pregnancy?
Use of the SpinalPak Stimulator System during pregnancy has not been evaluated; therefore, it’s not recommended.
Will my insurance cover the cost of the device?
Insurance coverage varies depending on your insurance plan. The SpinalPak Stimulator System is generally recognized by Medicare, Medicaid, worker’s compensation as well as private and public health plans. Zimmer Biomet’s Patient Advocacy Group is available to assist you and discuss any questions regarding insurance coverage, deductibles and potential out-of-pocket expenses. You may contact our Patient Advocacy Group at 1-888-236-3652.
Who do I contact if I have questions or need to order supplies?
Zimmer Biomet Customer Care Representatives are ready to answer your questions and can be reached at 1-800-526-2579 extension 6000.
Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day.
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:
Disabilities and Medical Conditions: https://www.tsa.gov/travel/special-procedures?field_disability_type_value=1%20
Please select “External Medical Devices” from the drop-down menu under:
Please choose a situation to see more information.*
TSA Notification Card: https://www.tsa.gov/sites/default/files/disability_notification_card_508.pdf
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
*The individuals depicted in the videos are actors.