510(k) · Cleared
ClearedChord-X Eptfe Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
On-Xlifetechnologies · PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Cleared on Aug 16, 2012 as substantially equivalent to K072076 (Osteogenics Biomedical, Inc., 2007) and 1 other predicate after a 121-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Aug 16, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- PAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K072076 (2007). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK072076 Cytoplast Ptfe SutureOsteogenics Biomedical, Inc. · 2007
- This deviceK121173 Chord-X Eptfe SutureOn-Xlifetechnologies · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072076 | Cytoplast Ptfe Suture | Osteogenics Biomedical, Inc. | 2007 | — |
| 0 (this device) | K121173 | Chord-X Eptfe Suture | On-Xlifetechnologies | 2012 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PAW device
- #1 K252126 MitraPatch Mitral Valve Repair Systemscore 10.8 · 2 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P820083 | Gore-Tex (R) Expanded Ptfe Suture FDA lists this PMA only through its supplements; the earliest we hold is P820083/S001 (May 12, 1986). Summary page 5…ylene surgical suture Classification Panel: Cardiovascular - Classification: 21CFR878.5035 Product code: PAW Class: II Substantial Equivalence: Gore-Tex ePTFE Suture — P820083 subsequently reclassified Osteogenics Cytoplast ePTFE Suture — K072076 Device Description The device is a non-absorbable monofi… | |
| * | K072076 | Cytoplast Ptfe SutureSummary page 5…ation: 21CFR878.5035 Product code: PAW Class: II Substantial Equivalence: Gore-Tex ePTFE Suture — P820083 subsequently reclassified Osteogenics Cytoplast ePTFE Suture — K072076 Device Description The device is a non-absorbable monofilament ePTFE suture provided in the following configurations and meetin… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate P820083.
How does its category compare?
All PAW devicesPAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PAW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAW
Too few PAW 510(k)s in any year since 2007 to give a median.
Recalls per year · PAW
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAW
4in 2025
MAUDE reports naming product code PAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Chord-X ePTFE Suture for chordae tendinae repair or replacement is indicated for the repair or replacement of chordae tendinae.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121173: Chord-X Eptfe Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121173
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026