# K261869: Integrity Retractable Implant Inserter (6000127)

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: Sep 17, 2026 after 105 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: 9 generations back to K961555 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223860: Integrity™ Bone Staple Fixation System, Anika Therapeutics, Inc. (2023) Summary page 5.

## Indications for use
The Integrity 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/K261869
Methodology: https://510kreport.com/methodology