| Note: 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. |
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| Device | AUGMENT BONE GRAFT |
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| Generic Name | Filler, bone void, synthetic peptide |
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| Applicant | BIOMIMETIC THERAPEUTICS,LLC
389 Nichol Mill Ln
FRANKLIN, TN 37067 |
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| PMA Number | P100006 |
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| Date Received | 02/04/2010 |
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| Decision Date | 09/01/2015 |
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| Product Code |
NOX |
| Docket Number | 15M-3257 |
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| Notice Date | 10/13/2015 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR AUGMENT® BONE GRAFT. THIS DEVICE IS INDICATED FOR USE AS AN ALTERNATIVE TO AUTOGRAFT IN ARTHRODESIS (I.E., SURGICAL FUSION PROCEDURES) OF THE ANKLE (TIBIOTALAR JOINT) AND/OR HINDFOOT (INCLUDING SUBTALAR, TALONAVICULAR, AND CALCANEOCUBOID JOINTS, ALONE OR IN COMBINATION), DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AVASCULAR NECROSIS, JOINT INSTABILITY, JOINT DEFORMITY, CONGENITAL DEFECT, OR JOINT ARTHROPATHY IN PATIENTS WITH PREOPERATIVE OR INTRAOPERATIVE EVIDENCE INDICATING THE NEED FOR SUPPLEMENTAL GRAFT MATERIAL. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012
S013 |
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