| 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 | Agili-C |
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| Generic Name | Implant, resorbable, for articular osteochondral repair |
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| Applicant | Smith and Nephew, Inc.
150 Minuteman Rd.
Andover, MA 01810 |
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| PMA Number | P210034 |
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| Date Received | 09/30/2021 |
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| Decision Date | 03/29/2022 |
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| Product Code |
QRU |
| Docket Number | 22M-0481 |
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| Notice Date | 03/30/2022 |
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| Advisory Committee |
Orthopedic |
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| Clinical Trials | NCT03299959
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for Agili-C. The Agili-C scaffold is indicated for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3). |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 |
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|
