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  1. Recently-Approved Devices

AccelStim Bone Growth Stimulator – P210035

AccelStim Bone Growth Stimulator – P210035

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:   AccelStim Bone Growth Stimulator
PMA Applicant:  Orthofix US LLC
Address:  3451 Plano Parkway, Lewisville, Texas 75056
Approval Date:   May 3, 2022
Approval Letter:  Approval order

What is it? 

The AccelStim Bone Growth Stimulator delivers a high frequency sound wave (ultrasound signal) to encourage bone growth and help heal broken bones (bone fractures). The portable, handheld, battery-powered device includes the following parts: 

  • A signal generator that controls the type of ultrasound signal needed
  • A transducer that produces the ultrasound signal
  • An external power supply/cord to power or charge the signal generator
  • A transducer holder with an elastic strap to hold the device over the fracture
  • Ultrasound gel to help the ultrasound signal flow from the transducer to the fracture

The AccelStim Bone Growth Stimulator device is prescribed by a doctor and used at home by the patient. 

How does it work? 

The AccelStim Bone Growth Stimulator delivers an ultrasound signal through the skin to the fracture site. The ultrasound signal stimulates bone tissue for bone growth and for the bones to start reconnecting (fusion). First, the patient receives standard treatments for their bone fracture, including a cast if needed. Then, the doctor prescribes the AccelStim for use at home. It is used for 20 minutes once each day or as directed by the doctor. 

When is it used?  

The AccelStim Bone Growth Stimulator is intended to treat bone fractures that are not healing on their own. Specifically, it is used to help bone fractures of the larger bone between the elbow and wrist (radius) or the larger long bone in the lower leg (tibia) heal faster. It is indicated for use in adults. 

What will it accomplish?  

The effectiveness of the AccelStim Bone Growth Stimulator is based on data from another, similar device, the Exogen Bone Healing System. Data from two clinical studies for that system, which produces a similar ultrasound signal to the AccelStim Bone Growth Stimulator, indicated that 108 fractures were treated without technical difficulties or any serious adverse events. The data also supported faster fracture healing in patients treated with the ultrasound signal device compared to those who did not receive ultrasound treatment. An evaluation of 74 non-healing (non-union) fractures submitted in a supplement for the Exogen system showed that 86% of those non-unions healed after treatment with the ultrasound signaling device. 

When should it not be used?  

The device should not be used to treat skull or spinal fractures. There are no other known reasons not to use this device. 

Additional information (including warnings, precautions, and adverse events):  

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