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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.
 
DeviceBIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Generic NameStimulator, bone growth, non-invasive
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850022
Supplement NumberS018
Date Received06/13/2011
Decision Date08/11/2011
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 MODIFICATION OF THE SYSTEM SOFTWARE TO INCLUDE AN ADDITIONAL LINE OF CODE WHICH WOULD ALLOW THE REAL-TIME CLOCK TO RESET TO 'DAY ZERO' AFTER AN ELAPSED 365 DAYS, THIS RESET WOULD ALLOW YOUR DEVICE TO REMAIN FUNCTIONAL AFTER 365 DAYS OF INACTIVITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM AND ARE INDICATED FOR THE FOLLOWING: 1) THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE 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 THE FRACTURE SITE SHOWS NO VISIBLE PROGRESSIVE SIGNS OF HEALING; AND 2) THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
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