# K031519: Cufflok Anchor

- Pathway: 510(k) (Special)
- Applicant: Mitek Worldwide
- Decided: Jun 6, 2003 after 22 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003076 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003076: Mitek Cufftack, Mitek Products (2000) Summary page 1.

## Indications for use
The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.

Source page: https://510kreport.com/device/K031519
Methodology: https://510kreport.com/methodology