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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantBIOMET, INC.
PMA NumberP850022
Supplement NumberS016
Date Received02/06/2006
Decision Date07/27/2006
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following device modifications: 1) the stimulator has been modified to include: a) a new user interface (similar to p850022/s015). The user interface includes an alarm button, yellow led, and a lcd display to indicate treating status; b) an audible and visible self-checking alarm mechanism with additional malfunction source indicators (same as p850022/s015). The audible alarm mechanism can be disabled using the alarm button; c) a new main pcb circuit board (same as p850022/s015); d) software c program language (same as p850022/s015); e) an elapsed time accumulator/patient monitoring function (similar to p850022/s015). After 270 days of elapsed treatment time or 400 days of total activation time the 7unit will no longer generate a signal. 2) the power source has been modified from a disposable battery to a rechargeable nimh "aa" battery. The device includes two rechargeable batteries and a single cell battery charger. The device, as modified, will be marketed under the trade name orthopak2 bone growth stimulator system and 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.
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