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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 MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix, Inc.
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS027
Date Received06/04/2003
Decision Date04/05/2005
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 TO MODIFY THE PHYSIO-STIM LITE, MODELS 202L, 303L, 215L, 313L, 314L AND SPINAL-STIM MODELS 212L AND 212LE AS FOLLOWS: 1) CHANGE THE POWER SOURCE FROM A 9-VOLT DISPOSABLE BATTERY TO AN 11.1-VOLT RECHARGEABLE; 2) CHANGE THE USER INTERFACE FROM A THREE COLOR LED TO A BACKLIT LCD DISPLAY; 3) CHANGE THE CIRCUIT ASSEMBLY FROM SEPARATE BOARDS FOR THE DRIVE CIRCUIT AND MICROCONTROLLER TO A SINGLE BOARD; 4) ADD AN OPTIONAL PERSONAL DATA ASSISTANT (PDA) THAT MAY BE USED TO SET DAILY SHUTDOWN TIME FOR ORTHOFIX PERSONNEL USE ONLY; AND 5) CHANGE THE SERIAL PORT CABLE ON THE COMPLIANCE PRINTER TO AN INFRARED PORT. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 ANDSPINAL-STIM MODEL 2212. THE PHYSIO-STIM MODELS ARE INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT 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 TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HEALING. THE SPINAL-STIM IS A NONINVASIVE ELECTROMAGNETIC BONE GROWTH STIMULATOR INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS AND AS A NONOPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE LAST SURGERY.
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