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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 II BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantBIOLECTRON, INC.
PMA NumberP850022
Supplement NumberS011
Date Received06/18/1998
Decision Date07/14/1998
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications:1)the "tombstone" - no part number a)change of indication b)minor grammatical corrections of labeling 2)the physician manual-part number 380-0001-0001-844 a)change of indication b)removed all references to "snap-on electrodes" (obsolete) c)reduced the number of sizes of foam spacers provided from two to one d)increased the number of leads provided from two to three (20" lead added) e)minor grammatical corrections of labeling 3)the patient manual - part number 380-0002-0001-844 a)change of indication b)removed all references to "snap-on electrodes" (obsolete) c)reduced the number of sizes of foam spacers provided from two to one d)increased the number of leads provided from two to three (20" lead added) e)added the section "electrode retainers" (copied from physician manual) f)minor grammatical corrections. The indication change listed above in each section is as follows: removal of the reference to a nine month clinical study time in the approved labels ("a non-union is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visible progressives signs of healing for a minimum of 3 months - no change in fracture callus") and to insert language as suggested in the fda letter of june 3, 1998 ("a nonunion is considered to be established when the fracture site shows no visible progressive signs of healing"). The device as modified, will be marketed under the trade name orthopak(r) and is indicated for treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where width of the defect is less than on-half the width of the defect is less than one-half the width of the bone to be treated.
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