Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System
Electrical Bone Growth Stimulation
The Soft-Touch® electrodes that accompany the system are lightweight and easily applied to the skin at the fracture nonunion 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.
Overview
The OrthoPak Stimulator System is a non-invasive, nonsurgical, medical device.
The OrthoPak 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 OrthoPak Stimulator System is easy to use, portable and battery operated.
- The device is a small, light-weight non-invasive bone growth stimulator which allows patients to treat while going about their daily routine.
- The Soft-Touch® electrodes means less weight placed at the fracture nonunion site.
- Compliance monitoring consistently tracks your treatment progress.
- Over 100,000 patients have been treated with the OrthoPak Stimulator System.1
- The OrthoPak Stimulator System is FDA approved and has more than 30 years of clinical use.2
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 OrthoPak Stimulator System works by sending low level electrical impulses directly to the nonunion fracture site via a pair of disposable electrodes. Two lightweight electrodes are placed on either side of the fracture nonunion site and positioned 180 degrees apart from each other. 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
Fracture Healing and Fracture Nonunion
Fracture 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, 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
Getting Started
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System
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
Charging the Battery Packs
Connecting the Electrodes
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.
Two lightweight electrodes similar in size to a quarter are placed on either side of the fracture nonunion site and should be positioned 180 degrees apart from each other. A small or slight misalignment in electrode placement is allowable. The exact placement of the electrodes should be left up to the discretion of your prescribing physician.
Beginning Treatment
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:
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The blinking checkmark symbol indicates that the controller is treating;
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The battery symbol indicates the amount of remaining battery life;
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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 Information included with your system assembly for detailed descriptions of each symbol.
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Soft-Touch® Electrodes
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 ZimVie’s Customer Service team at 1-800-526-2579, extension 6000.
Electrode Placement Instructions
The Soft-Touch® electrodes that accompany the OrthoPak Stimulator System are intended to be placed 180 degrees on either side of the fracture nonunion site.
Click the image below to view a gallery of videos intended to provide proper electrode guidance for some of the most common fracture nonunion locations.*
The OrthoPak Electrode Placement Guide illustrates the typical placement of electrodes for the most common types of fracture nonunion locations.
Frequently Asked Questions
The Bone Healing System
How can I obtain an OrthoPak Stimulator System?
I have a pacemaker. Can I use the system?
My doctor prescribed a cam walking fracture boot or wrist splint/brace. Can I use the OrthoPak system while wearing these?
Is the system MRI safe?
Is the system safe to use during pregnancy?
Will my insurance cover the cost of the device?
Who do I contact if I have questions or need to order supplies?
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_50
Product Resources
Manuals
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System Complete Manual and Package Insert Physician Manual
PN# 1067799-00 REV G, ZV1186 REV B 02/24Download PDFBiomet® OrthoPak® Non-invasive Bone Growth Stimulator System Patient Manual
PN# 1067800-00 REV G, ZV1298 REV B 02/24Download PDFVideos
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.
Additional Information
References
- Data on file at Zimmer Biomet – ZBDATA1_20
- Data on file Zimmer Biomet – P850022
- https://nyulangone.org/conditions/nonhealing-fractures-in-adults/diagnosis
*The individuals depicted in the videos are actors.
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.
Customer service can assist with:
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Answering product related questions
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Placing orders for additional supplies, such as electrodes
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Reporting an adverse event or product complaint