Medical Device Manufacturer · US , Beford , MA

Anika Therapeutics, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2017

Total

Cleared

Denied

Anika Therapeutics, Inc. is a global leader in hyaluronic acid-based orthopedic regenerative solutions and osteoarthritis pain management. The company develops advanced tissue repair, cartilage regeneration, and injectable bone substitute technologies with a manufacturing facility in Bedford, US.

Anika has received 9 FDA 510(k) clearances from 9 total submissions since 2017. Orthopedic devices represent the dominant focus of the company's regulatory portfolio. The latest clearance was received in 2025, reflecting active ongoing innovation and market engagement.

The company's cleared device portfolio includes regenerative solutions such as the Integrity™ Implant for rotator cuff and tendon repair, Hyalofast® for cartilage regeneration, and Tactoset® Injectable Bone Substitute. Anika also markets osteoarthritis pain management products including Cingal®, Monovisc®, and Orthovisc®. Products are available in over 45 countries worldwide.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database.

Regulatory submissions have been managed by Musculoskeletal Clinical Regulatory Advisers, LLC and Mcra, LLC.

FDA 510(k) Regulatory Record - Anika Therapeutics, Inc.

9 devices

1-9 of 9

Tactoset® Injectable Bone Substitute

K231968 · MQV