FDA.reportPublic FDA data

PMA P850007S027

Device
PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S027
Product code
LOF
Decision date
2005-04-05
Classification
Stimulator, Bone Growth, Non-invasive
Generic name
Stimulator, bone growth, non-invasive
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.

Current openFDA PMA Record#

Device
PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S027
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2005-04-05
Decision code
APPR
Date received
2003-06-04
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.