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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 LITE BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix, Inc.
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS018
Date Received05/07/1996
Decision Date04/16/1997
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DESIGN AND LABELING OF THE PHYSIO-STIM(R) BONE GROWTH STIMULATOR. THE DEVICE, AS MODIFIED, IS TO BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM(R) LITE AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING BERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE INJURY AND THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HELAING FOR A MINIMUM OF THREE MONTHS (NO CHANGE IN THE FRACTURE CALLUS)
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