Agili-C
FDA premarket approval P210034 · decided 2022-03-29
Approval details
- PMA number
- P210034
- Trade name
- Agili-C
- Generic name
- Implant, resorbable, for articular osteochondral repair
- Applicant
- Smith and Nephew, Inc.
- Date received
- 2021-09-30
- Decision date
- 2022-03-29
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- QRU
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Andover, MA
- 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).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Regeneten Bioinductive Implant (K222501) | Smith and Nephew, Inc. | 2023-05-11 |
| SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) (K221740) | Smith and Nephew, Inc. | 2022-10-20 |
| LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (K191177) | Smith and Nephew, Inc. | 2019-08-23 |
| Double ENDOBUTTON Fixation Device (K183232) | Smith and Nephew, Inc. | 2019-03-12 |
| MICRORAPTOR Knotless Suture Anchor (K181746) | Smith and Nephew, Inc. | 2018-09-28 |
| MICRORAPTOR REGENESORB Suture Anchor (K180361) | Smith and Nephew, Inc. | 2018-05-30 |
| SUTUREFIX Curved Suture Anchor (K163034) | Smith and Nephew, Inc. | 2016-12-07 |