This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the infuse bone graft. The device is indicated for treating acute, open tibial shaft fractures that have been stabilized with im nail fixation after appropriate wound management. Infuse bone graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.
| Device | INFUSE BONE GRAFT |
| Classification Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction |
| Generic Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2000-12-20 |
| Decision Date | 2004-04-30 |
| Notice Date | 2004-05-26 |
| PMA | P000054 |
| Supplement | S |
| Product Code | MPW |
| Docket Number | 04M-0249 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000054 | Original Filing | |
| S068 | 2022-07-21 | 30-day Notice |
| S067 | 2022-05-10 | 30-day Notice |
| S066 | 2022-01-20 | 30-day Notice |
| S065 | 2021-03-09 | 30-day Notice |
| S064 | 2021-01-15 | 30-day Notice |
| S063 | 2020-07-30 | 30-day Notice |
| S062 | ||
| S061 | ||
| S060 | ||
| S059 | 2020-06-11 | 30-day Notice |
| S058 | 2019-11-04 | 30-day Notice |
| S057 | 2019-10-31 | 30-day Notice |
| S056 | 2019-09-25 | 30-day Notice |
| S055 | ||
| S054 | ||
| S053 | 2019-06-28 | 30-day Notice |
| S052 | 2018-10-17 | Normal 180 Day Track |
| S051 | 2018-10-02 | 30-day Notice |
| S050 | 2018-08-02 | 30-day Notice |
| S049 | 2017-11-13 | 30-day Notice |
| S048 | 2017-05-23 | 30-day Notice |
| S047 | ||
| S046 | 2017-02-03 | 30-day Notice |
| S045 | 2017-01-23 | 30-day Notice |
| S044 | 2016-06-21 | Normal 180 Day Track |
| S043 | 2014-10-27 | Normal 180 Day Track No User Fee |
| S042 | 2014-01-27 | Normal 180 Day Track |
| S041 | ||
| S040 | 2013-10-25 | Real-time Process |
| S039 | 2013-03-07 | Special (immediate Track) |
| S038 | 2013-02-26 | 30-day Notice |
| S037 | 2013-01-14 | 30-day Notice |
| S036 | 2012-12-21 | 30-day Notice |
| S035 | 2012-08-21 | 135 Review Track For 30-day Notice |
| S034 | 2011-12-19 | Normal 180 Day Track |
| S033 | 2011-10-20 | Special (immediate Track) |
| S032 | 2011-10-04 | 135 Review Track For 30-day Notice |
| S031 | 2011-06-16 | 135 Review Track For 30-day Notice |
| S030 | 2011-02-15 | 135 Review Track For 30-day Notice |
| S029 | 2011-01-13 | 30-day Notice |
| S028 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S027 | 2010-09-30 | 135 Review Track For 30-day Notice |
| S026 | 2010-09-01 | Normal 180 Day Track No User Fee |
| S025 | 2010-06-03 | 135 Review Track For 30-day Notice |
| S024 | 2010-02-24 | Special (immediate Track) |
| S023 | 2009-09-01 | 135 Review Track For 30-day Notice |
| S022 | 2009-03-25 | 135 Review Track For 30-day Notice |
| S021 | 2009-03-16 | Special (immediate Track) |
| S020 | 2008-12-23 | Real-time Process |
| S019 | 2008-11-21 | 135 Review Track For 30-day Notice |
| S018 | 2008-08-29 | 135 Review Track For 30-day Notice |
| S017 | 2008-01-14 | 135 Review Track For 30-day Notice |
| S016 | 2007-11-16 | Normal 180 Day Track No User Fee |
| S015 | 2007-11-06 | Normal 180 Day Track No User Fee |
| S014 | ||
| S013 | 2007-07-31 | 135 Review Track For 30-day Notice |
| S012 | ||
| S011 | 2007-04-06 | 135 Review Track For 30-day Notice |
| S010 | 2006-12-22 | 135 Review Track For 30-day Notice |
| S009 | 2006-10-27 | Normal 180 Day Track |
| S008 | 2006-10-12 | Special (immediate Track) |
| S007 | ||
| S006 | 2005-02-22 | Real-time Process |
| S005 | 2005-02-04 | 135 Review Track For 30-day Notice |
| S004 | 2005-01-26 | Real-time Process |
| S003 | 2004-09-17 | 135 Review Track For 30-day Notice |
| S002 | 2004-08-02 | Real-time Process |
| S001 | 2004-05-20 | Real-time Process |