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About the Device

Electrical Spine Fusion Stimulation

Bone Growth Stimulation

Electrical stimulation of the spine is the application of an external, electric 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 you have specific risk factors or an underlying medical condition that may compromise normal healing.

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

SpinalPak-Circle-Graphic

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 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.
  • It’s the smallest and lightest non-invasive spinal fusion stimulator on the market allowing patients to treat while going about their daily routine.1
  • The Soft-Touch® electrodes can be comfortably worn under a brace.
  • Compliance monitoring consistently tracks your treatment progress.
  • Over 400,000 patients have been treated with the SpinalPak Stimulator System.2
  • The SpinalPak Stimulator System is FDA approved and has more than 30 years of clinical use in improving patients’ lives.3

 

Watch this short video to learn more about the SpinalPak Stimulator System

 

How it works

How does SpinalPak work?

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 2-3 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.

Recommended use

Posterolateral Fusion

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. 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.

Click here to download a copy of the patient brochures and manuals which contain information and answers to commonly asked questions.

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 noninvasive spine fusion stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.

USAGE: 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.

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

  1. Data on file at Zimmer Biomet – P&R17341A
  2. Data on file at Zimmer Biomet – ZBDATA1_20
  3. Data on file Zimmer Biomet – P850022

*The person depicted in the videos herein is a paid actress and not a patient

For product information, talk to your healthcare provider and visit www.LearnAboutBoneHealing.com.
All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet.  
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