# K223538: Integrity Implant

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: Aug 17, 2023 after 267 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: 5 generations back to K850785 (1985). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112423: Collagen Tendon Sheet, Rotation Medical, Inc. (2011) Summary page 4.

## Most influential descendants
- K250997: Integrity™ Implant (2025), 0 descendants of its own

## 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/K223538
Methodology: https://510kreport.com/methodology