|Trade Name||PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES|
|Classification Name||filler, bone void, non-osteoinduction|
|Generic Name||bone graft non-osteogenic|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for several labeling changes as identified and agreed upon in an april 17, 1998 facsimile of the labeling. The device name will also be modified and will be marketed under the trade name "pro osteon(r) implant 500 porous hydroxyapatite bone graft substitute blocks and granules. " the device is indicated for the repair of metaphyseal fracture defects and long bone cyst and tumor defects. For metaphyseal fracture defects, the device is indicated for treatment which occurs within one month of fracture. The device is to be used in conjunction with rigid internal fixation as dictated by the clinical use requirements in skeletally mature individuals.