# K051488: Medicinelodge Zipknot

- Pathway: 510(k) (Traditional)
- Applicant: Medicinelodge, Inc.
- Decided: Jul 27, 2005 after 51 days
- Product code: NVH (Suture, Knot, Mechanical)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K033654 (2004). 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)
- K041216: Smith & Nephew Ultrabraid Suture, Smith & Nephew, Inc. (2004) Summary page 5.

## Indications for use
The MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

Source page: https://510kreport.com/device/K051488
Methodology: https://510kreport.com/methodology