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.
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.
| Device | PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | INTERPORE INTL. |
| Date Received | 1997-10-27 |
| Decision Date | 1998-04-28 |
| PMA | P860005 |
| Supplement | S009 |
| Product Code | MBS |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTERPORE INTL. 181 Technology Dr. irvine, CA 92618-2402 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860005 | Original Filing | |
| S012 | 2001-12-04 | Normal 180 Day Track |
| S011 | 1999-04-22 | Normal 180 Day Track |
| S010 | 1997-11-18 | Normal 180 Day Track |
| S009 | 1997-10-27 | Normal 180 Day Track |
| S008 | 1997-08-28 | Normal 180 Day Track |
| S007 | 1997-05-15 | Normal 180 Day Track |
| S006 | ||
| S005 | 1996-04-29 | Normal 180 Day Track |
| S004 | 1994-02-22 | Normal 180 Day Track |
| S003 | 1993-10-15 | Normal 180 Day Track |
| S002 | 1993-03-23 | Normal 180 Day Track |
| S001 | 1993-02-08 | Normal 180 Day Track |