# K222487: Anika Tissue Tack Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: May 8, 2023 after 264 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951658 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131637: Rotation Medical Soft Tissue Staple (RMST Staple), Rotation Medical, Inc. (2013) Summary page 4.

## Indications for use
The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.

Source page: https://510kreport.com/device/K222487
Methodology: https://510kreport.com/methodology