# Anika Therapeutics, Inc.

- Location (FDA's records): Beford, MA
- FDA decisions: 15 (2001–2026): 11 510(k) clearances and 4 original PMA approvals
- Product codes: MQV (5), OWX (2), MBI (2), MOZ (2), LMH (1), GDW (1), LZP (1), QSZ (1)
- 510(k) review time since 2016: median 134 days, against 88 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 20 (9 its own); citations of its devices by later devices: 9 (9 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rotation Medical, Inc.: 3 (https://510kreport.com/company/rotation-medical)
- Bonesupport AB: 2 (https://510kreport.com/company/bonesupport)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Kuros Biosciences B.V: 1 (https://510kreport.com/company/kuros-biosciences-b-v)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Orthovita, Inc.: 1 (https://510kreport.com/company/orthovita)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Fidia Advanced Biopolymers Srl: 1 (https://510kreport.com/company/fidia-advanced-biopolymers)

## Its most-cited devices
- K173008: SCS 17-01 (2017), cited by 3
- K212083: Tactoset Injectable Bone Substitute (2021), cited by 2
- K190956: SCS 17-01 (2020), cited by 1
- K223915: Tactoset (2023), cited by 1
- K223538: Integrity Implant (2023), cited by 1
- K223860: Integrity™ Bone Staple Fixation System (2023), cited by 1

## Recent decisions
- K261869: Integrity Retractable Implant Inserter (6000127) (Sep 17, 2026)
- K261311: Hyalomatrix (Sep 2, 2026)
- K250997: Integrity™ Implant (Jun 17, 2025)
- K231968: Tactoset® Injectable Bone Substitute (Dec 20, 2023)
- K223538: Integrity Implant (Aug 17, 2023)
- K223860: Integrity™ Bone Staple Fixation System (May 22, 2023)
- K222487: Anika Tissue Tack Fixation System (May 8, 2023)
- K223915: Tactoset (Mar 29, 2023)

Source page: https://510kreport.com/company/anika-therapeutics
