510(k) · Cleared
ClearedAesculap Monomax Absorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · NWJ Suture, Recombinant Technology
Cleared on Jul 14, 2010 as substantially equivalent to K082178 (Tepha, Inc., 2008) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Jul 14, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- NWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to DEN060003 (2007). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backDEN060003 Tephaflex Absorbable SutureTepha, Inc. · 2007
- This deviceK100876 Aesculap Monomax Absorbable SutureAesculap, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN060003 | Tephaflex Absorbable Suture | Tepha, Inc. | 2007 | — |
| 0 (this device) | K100876 | Aesculap Monomax Absorbable Suture | Aesculap, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K082178 | Tephaflex Absorbable SutureSummary page 1…NWJ SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the MonoMax Absorbable Suture is substantially equivalent to the TephaFLEX® Absorbable Suture (K0821 78/K081 099/K052225). DEVICE DESCRIPTION The Aesculap® MonoMax Absorbable Sutures are sterile, monofilament, absorbable surgical su… | 2008 |
| * | K081099 | Tephaflex Absorbable SutureSummary page 1…NWJ SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the MonoMax Absorbable Suture is substantially equivalent to the TephaFLEX® Absorbable Suture (K0821 78/K081 099/K052225). DEVICE DESCRIPTION The Aesculap® MonoMax Absorbable Sutures are sterile, monofilament, absorbable surgical sutures con… | 2008 |
| * | DEN060003 | Tephaflex Absorbable Suture Our reading of the summary gave K052225, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060003, Tephaflex Absorbable Suture (Tepha, Inc.), granted Feb 8, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 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?
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K082178.
How does its category compare?
All NWJ devicesNWJ Suture, Recombinant Technology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
MonoMax 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/K100876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100876: Aesculap Monomax 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/K100876
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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