Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anika Therapeutics, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
294 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250997 | Integrity™ Implant | Anika Therapeutics, Inc. | 2025-06-17 | 77 | 0 |
| K231968 | Tactoset® Injectable Bone Substitute | Anika Therapeutics, Inc. | 2023-12-20 | 170 | 0 |
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | 2023-08-17 | 267 | 0 |
| K223860 | Integrity™ Bone Staple Fixation System | Anika Therapeutics, Inc. | 2023-05-22 | 150 | 0 |
| K222487 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | 2023-05-08 | 264 | 0 |
| K223915 | Tactoset | Anika Therapeutics, Inc. | 2023-03-29 | 90 | 0 |
| K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021-08-31 | 60 | 0 |
| K190956 | SCS 17-01 | Anika Therapeutics, Inc. | 2020-01-30 | 294 | 0 |
| K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017-12-26 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda