510(k) · Cleared
ClearedTephaflex 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
Cleared on Jul 15, 2008 after an 89-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 15, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- NWJ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK081099 Tephaflex Absorbable SutureTepha, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK122487 Biofiber SytureTornier, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK130422 Phantom Fiber Biofiber SutureTornier, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK132348 Tephaflex Braided SutureTepha, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK100876 Aesculap Monomax Absorbable SutureAesculap, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K122487Biofiber SytureTornier, Inc. · 2012 · cites it directly2descendants
- K130422Phantom Fiber Biofiber SutureTornier, Inc. · 2013 · 2 generations on1descendant
- K132348Tephaflex Braided SutureTepha, Inc. · 2013 · 2 generations on0descendants
- K100876Aesculap Monomax Absorbable SutureAesculap, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081099 | Tephaflex Absorbable Suture | Tepha, Inc. | 2008 | — |
| +1 | K122487 | Biofiber Syture | Tornier, Inc. | 2012 | — |
| +2 | K130422 | Phantom Fiber Biofiber Suture | Tornier, Inc. | 2013 | 1 |
| +2 | K132348 | Tephaflex Braided Suture | Tepha, Inc. | 2013 | — |
| +1 | K100876 | Aesculap Monomax Absorbable Suture | Aesculap, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Tepha, Inc., TephaFLEX Absorbable Suture Named without a submission number | |
| * | — | ENTrigue Surgical, Inc., BioElast™ Absorbable suture Named without a submission number | |
| * | — | Ethicon, Inc., PDS II Absorbable Suture Named without a submission number |
What descends from it? (4)
2 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, K122487 (Tornier, Inc., 2012) has gone furthest, with 2 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. 2008, 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 | — |
What is it indicated for?
TephaFLEX absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081099: Tephaflex Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081099
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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