Chrysalis Intelligence · Sponsors · Anika Therapeutics, Inc.

Anika Therapeutics, Inc.

Beford, MA, US · 8 510(k) clearances · 15 PMAs

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Total clearances
8
2020-01-30 → 2025-06-17
Last 12 months
0
Product codes
4
Most recent
2025-06-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MQV Filler, Bone Void, Calcium Compound Class II Orthopedic 4 2023-12-20
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon Class II General, Plastic Surgery 2 2025-06-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 1 2023-05-22
GDW Staple, Implantable Class II General, Plastic Surgery 1 2023-05-08
Class III

PMA approvals (15)

Total PMA records
15
Originals + supplements
Distinct product codes
2
First decision
2020-01-09
Most recent
2025-10-15
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2025-10-15 P000046-S031 Ophthalin; Nuvisc; Anikavisc 30-Day Notice LZP — —
2023-08-08 P090031-S016 Monovisc 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-11-08 P090031-S015 Monovisc High Molecular Weight Hyaluronan 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-11-08 P030019-S027 Orthovisc, Sodium Hyaluronic 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-11-04 P090031-S014 Monovisc High Molecular Weight Hyaluronan 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-07-13 P090031-S013 Monovisc High Molecular Weight Hyaluronan 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2021-12-22 P000046-S030 Ophthalin, Anikavisc, Nuvisc Normal 180 Day Track No User Fee LZP — —
2021-10-21 P000046-S029 Nuvisc, Anikavisc, Ophthalin Normal 180 Day Track No User Fee LZP — —
2021-10-13 P090031-S012 Monovisc High Molecular Weight Hyaluronan 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2021-10-13 P090031-S011 Monovisc High Molecular Weight Hyaluronan 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2021-09-03 P090031-S010 Monovisc High Molecular Weight Hyaluronan 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2021-07-02 P030019-S026 Orthovisc 135 Review Track For 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2021-06-02 P000046-S028 Ophthalmic 30-Day Notice LZP — —
2020-12-08 P030019-S025 Orthovisc 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2020-01-09 P090031-S009 Monovisc Normal 180 Day Track MOZ Acid, Hyaluronic, Intraarticular Unknown
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2025-06-17 K250997 Integrity™ Implant OWX Class II General, Plastic Surgery
2023-12-20 K231968 Tactoset® Injectable Bone Substitute MQV Class II Orthopedic
2023-08-17 K223538 Integrity Implant OWX Class II General, Plastic Surgery
2023-05-22 K223860 Integrity™ Bone Staple Fixation System MBI Class II Orthopedic
2023-05-08 K222487 Anika Tissue Tack Fixation System GDW Class II General, Plastic Surgery
2023-03-29 K223915 Tactoset MQV Class II Orthopedic
2021-08-31 K212083 Tactoset Injectable Bone Substitute MQV Class II Orthopedic
2020-01-30 K190956 SCS 17-01 MQV Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence