# K223860: Integrity™ Bone Staple Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: May 22, 2023 after 150 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K961555 (1996). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131635: Rotation Medical Bone Staple (RMB Staple), Rotation Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K261869: Integrity Retractable Implant Inserter (6000127) (2026), 0 descendants of its own

## Indications for use
The IntegrityTM Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.

Source page: https://510kreport.com/device/K223860
Methodology: https://510kreport.com/methodology