ORTHOVISC SODIUM HYALURONATE
FDA premarket approval P030019/S009 · decided 2007-10-26
Approval details
- PMA number
- P030019
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORTHOVISC SODIUM HYALURONATE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2006-04-28
- Decision date
- 2007-10-26
- Days to decision
- 546 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR MODIFYING THE MANUFACTURING PROCESS FOR ORTHOVISC TO ONE THAT PRODUCES SODIUM HYALURONATE FROM BACTERIAL FERMENTATION. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
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510(k) clearances by this applicant
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|---|---|---|
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
| Tactoset® Injectable Bone Substitute (K231968) | Anika Therapeutics, Inc. | 2023-12-20 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
| Integrity™ Bone Staple Fixation System (K223860) | Anika Therapeutics, Inc. | 2023-05-22 |
| Anika Tissue Tack Fixation System (K222487) | Anika Therapeutics, Inc. | 2023-05-08 |
| Tactoset (K223915) | Anika Therapeutics, Inc. | 2023-03-29 |
| Tactoset Injectable Bone Substitute (K212083) | Anika Therapeutics, Inc. | 2021-08-31 |
| SCS 17-01 (K190956) | Anika Therapeutics, Inc. | 2020-01-30 |