# K250997: Integrity™ Implant

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: Jun 17, 2025 after 77 days
- Product code: OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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 K850785 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223538: Integrity Implant, Anika Therapeutics, Inc. (2023) Summary page 5.

## Indications for use
The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Source page: https://510kreport.com/device/K250997
Methodology: https://510kreport.com/methodology