Anika Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Anika Therapeutics, Inc.” (first 2017, latest 2026), plus 4 PMA decisions, across 8 product codes in 3 review panels. Median 510(k) review time under this name: 134 days. Since 2017 the median was 134 days, against 89 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 294 |
| 2021 | 1 | 60 |
| 2022 | 0 | — |
| 2023 | 5 | 170 |
| 2024 | 0 | — |
| 2025 | 1 | 77 |
| 2026 | 2 | 120 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Anika Therapeutics, Inc. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 5 | 5 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| MOZ | Acid, Hyaluronic, Intraarticular | 2 | 0 |
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | 2 | 2 |
| GDW | Staple, Implantable | 1 | 1 |
| LMH | Implant, Dermal, For Aesthetic Use | 1 | 0 |
| LZP | Aid, Surgical, Viscoelastic | 1 | 0 |
| QSZ | Absorbable Synthetic Wound Dressing | 1 | 1 |
Review panels
- Orthopedic (11)
- General and Plastic Surgery (3)
- Ophthalmic (1)
Most recent Anika Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261869 | Integrity Retractable Implant Inserter (6000127) | MBI | 2026-09-17 | 105 |
| K261311 | HYALOMATRIX | QSZ | 2026-09-02 | 134 |
| K250997 | Integrity Implant | OWX | 2025-06-17 | 77 |
| K231968 | Tactoset® Injectable Bone Substitute | MQV | 2023-12-20 | 170 |
| K223538 | Integrity Implant | OWX | 2023-08-17 | 267 |
| K223860 | Integrity Bone Staple Fixation System | MBI | 2023-05-22 | 150 |
| K222487 | Anika Tissue Tack Fixation System | GDW | 2023-05-08 | 264 |
| K223915 | Tactoset | MQV | 2023-03-29 | 90 |
| K212083 | Tactoset Injectable Bone Substitute | MQV | 2021-08-31 | 60 |
| K190956 | SCS 17-01 | MQV | 2020-01-30 | 294 |
1 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P090031 | PMA | MONOVISC | 2014-02-25 |
| P050033 | PMA | HYDRELLE | 2006-12-20 |
| P030019 | PMA | ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN | 2004-02-04 |
| P000046 | PMA | STAARVISC II | 2001-04-18 |
Recalls
13 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2018-05-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Anika Therapeutics, Inc. is the lead sponsor of 14 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06741527: Integrity Implant System Post Market Clinical Follow-Up Study (Recruiting, started 2025-02-01)
- NCT04640961: Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint (Completed, started 2021-01-16)
- NCT04640298: Study of Cingal® for Symptomatic Relief of Osteoarthritis of Hip Joint (Completed, started 2021-01-16)
- NCT04640974: Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint (Completed, started 2021-01-14)
- NCT04204265: MONOVISC for Shoulder Joint Pain Relief Due to Osteoarthritis (Completed, started 2019-12-17)
SEC filings
Anika Therapeutics, Inc. (ANIK): EDGAR filings, CIK 898437. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Anika Therapeutics, Inc. (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via LMH)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via LMH)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via LMH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Anika Therapeutics, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Anika Therapeutics, Inc.” (first 2017, latest 2026), plus 4 PMA decisions, across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Anika Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anika Therapeutics, Inc. is 134 days. Since 2017: 134 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Anika Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 5); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2); MOZ (Acid, Hyaluronic, Intraarticular, 2).
Next steps
- See all 11 Anika Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Anika Therapeutics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.