# K060553: RC Loop /Dual Orthocord Suture,RC Loop W/Ethibond Suture,RC Loop W/Panacryl Suture

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: May 4, 2006 after 64 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: 2 generations back to K964013 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041065: Panalok RC Loop Anchor, Depuy Mitek (2004) Summary page 1.

## Indications for use
The RC Loop Anchor with Dual Orthocord Suture is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Rotator cuff repair

Source page: https://510kreport.com/device/K060553
Methodology: https://510kreport.com/methodology