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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAccelStim
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantOrthofix US, LLC
3451 Plano Pkwy.
Lewisville, TX 75056
PMA NumberP210035
Supplement NumberS003
Date Received09/09/2024
Decision Date03/21/2025
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an updated "next generation/AccelStim 2.0" version of the AccelStim device to include modifications to the controller user interface, ergonomics, aesthetics, and the integration of Bluetooth data transfer for connectivity with the optional Stim onTrack mobile application. The Stim onTrack mobile application has also been updated to optionally incorporate activity tracker data.
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