# K041064: Bioknotless RC Anchor

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek
- Decided: May 13, 2004 after 20 days
- Product code: JDR (Staple, Fixation, Bone)
- 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 K964013 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002639: Bioknotless Anchor, Mitek Products (2001) Summary page 2.
- K964013: Mitek Absorbable Toggle Anchor, Mitek Products (1997) Summary page 2.

## Indications for use
The Mitek BIOKNOTLESS RC Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.

Source page: https://510kreport.com/device/K041064
Methodology: https://510kreport.com/methodology