DEVICE: EXOGEN® Ultrasound Bone Healing System (M937710344001)

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Device Record History
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Device Identifier (DI) Information
EXOGEN® Ultrasound Bone Healing System
71034400
In Commercial Distribution
71034400
BIOVENTUS LLC
M937710344001
HIBCC

1
078450878 *Terms of Use
The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
18154 Bone growth ultrasonic stimulator
A mains electricity (AC-powered) device designed to accelerate bone formation (osteogenesis) through the application of ultrasound energy. It typically consists of a pulsed low-intensity ultrasound generator that includes a transducer probe and a retaining and alignment fixture for the probe. The device is typically used to promote healing of nonunion fractures; it is also used to speed the healing of fresh fractures.
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40805 Radiographic image marker, manual
An object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.
Active false
15321 Skin topical coupling gel
A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.
Active false
31072 Personal device holder, single-use
A portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.
Active false
17115 Noninvasive device battery charger
An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.
Active false
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FDA Product Code

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Product Code Product Code Name
LOF Stimulator, Bone Growth, Non-Invasive
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P900009 035
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 32 Degrees Celsius
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 32 Degrees Celsius
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
da815334-5d55-4f2d-8e5d-1e91d76ebe17
April 04, 2023
10
January 12, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
No
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Customer Contact

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1-800-836-4080
CTServicesCenter@bioventusglobal.com
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