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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.
 
DevicePHYSIO-STIM & SPINAL-STIM
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix, Inc.
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS028
Date Received05/07/2009
Decision Date07/10/2009
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RELOCATION AND CHANGE OF THE CHARGE MANAGEMENT CONTROLLER AND THE REPLACEMENT OF THE CHARGER UNIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM AND SPINAL-STIM. THE PHYSIO-SLIM IS INDICATED FOR THETREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALLFLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECTS IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED LO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLYPROGRESSIVE SIGNS OF HEALING. THE SPINAL-SLIM IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASETHE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE LAST SURGERY.
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