Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: AccelStimTM Bone Growth Stimulator
• Generic Name: Stimulator, bone growth, non-invasive
• Regulation Number: 890.5870
• Applicant: Orthofix US, LLC; 3451 Plano Pkwy.; Lewisville, TX 75056
• PMA Number: P210035
• Date Received: 10/13/2021
• Decision Date: 05/03/2022
• Reclassified Date: 05/18/2026
• Product Code: LOF
• Docket Number: 22M-0751
• Notice Date: 05/06/2022
• Advisory Committee: Orthopedic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the AccelStim Ultrasound Bone Growth Stimulator, a non-invasive Low-Intensity Pulsed Ultrasound (LIPUS) device intended to aid fracture healing. The device is Rx only, and intended for single patient use in adult patients only.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S002 S003