De Novo · Granted
GrantedTephaflex Absorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tepha, Inc. · NWJ Suture, Recombinant Technology
Granted on Feb 8, 2007 as a new device type through De Novo after a 272-day review. 22 later devices descend from it.
- Decided
- Feb 8, 2007
- Review
- 272 days
- Class
- Class II
- Product code
- NWJ
- Recalls
- None
22 later devices descend from it, 4 citing it directly.
- This deviceDEN060003 Tephaflex Absorbable SutureTepha, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK143380 Phasix ST MeshC.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK142818 Phasix MeshC. R. Bard · 2015
- Descendant · 2 generations on · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK161424 Phasix MeshC.R. Bard, Inc. · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K070894Tephaflex Surgical MeshTepha, Inc. · 2007 · cites it directly17descendants
- K143380Phasix ST MeshC.R. Bard, Inc. · 2015 · 2 generations on4descendants
- K142818Phasix MeshC. R. Bard · 2015 · 2 generations on3descendants
- K140533Galaflex MeshTepha, Inc. · 2014 · 2 generations on3descendants
- K161424Phasix MeshC.R. Bard, Inc. · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN060003 | Tephaflex Absorbable Suture | Tepha, Inc. | 2007 | — |
| +1 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| +2 | K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015 | — |
| +2 | K142818 | Phasix Mesh | C. R. Bard | 2015 | — |
| +2 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| +3 | K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NWJ? 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 NWJ device
- #1 K211307 GalaSTITCH Absorbable Monofilament Suturescore 1.4 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K070894 (Tepha, Inc., 2007) has gone furthest, with 17 descendants of its own.
How does its category compare?
All NWJ devicesNWJ Suture, Recombinant Technology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NWJ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NWJ
Too few NWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NWJ
No recall names NWJ since 2007.
Adverse event reports per year · NWJ
4in 2025
MAUDE reports naming product code NWJ, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN060003 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN060003: Tephaflex Absorbable Suture.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN060003
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026