# K121173: Chord-X Eptfe Suture

- Pathway: 510(k) (Abbreviated)
- Applicant: On-Xlifetechnologies
- Decided: Aug 16, 2012 after 121 days
- Product code: PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement)
- Device class: 2
- Regulation: 21 CFR 870.3470
- 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 K072076 (2007). 2 ancestors 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)
- P820083: Gore-Tex (R) Expanded Ptfe Suture, W. L. Gore & Associates, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P820083/S001 (May 12, 1986). Summary page 5.
- K072076: Cytoplast Ptfe Suture, Osteogenics Biomedical, Inc. (2007) Summary page 5.

## Indications for use
Chord-X ePTFE Suture for chordae tendinae repair or replacement is indicated for the repair or replacement of chordae tendinae.

Source page: https://510kreport.com/device/K121173
Methodology: https://510kreport.com/methodology