510(k) · Cleared
ClearedTephaflex Composite Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tepha, Inc. · OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Cleared on Aug 30, 2010 after a 115-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Aug 30, 2010
- Review
- 115 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK101287 Tephaflex Composite MeshTepha, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK161092 GalaSHAPE 3DTepha, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK202425 SurgiLattice scaffoldTepha, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK162922 GalaFORM 3DTepha, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101287 | Tephaflex Composite Mesh | Tepha, Inc. | 2010 | — |
| +1 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| +2 | K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016 | 1 |
| +2 | K202425 | SurgiLattice scaffold | Tepha, Inc. | 2021 | — |
| +2 | K162922 | GalaFORM 3D | Tepha, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 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 OWT? 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 OWT device
- #1 K261543 Phasix ST Parastomal Hernia Meshscore 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | TephaFLEX Surgical Film Named without a submission number | |
| * | — | TephaFLEX Surgical Mesh Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140533 | Galaflex Mesh | 2014 | 3 |
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, K140533 (Tepha, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OWT devicesOWT Mesh, Surgical, Absorbable, Abdominal Hernia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OWT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWT
Too few OWT 510(k)s in any year since 2007 to give a median.
Recalls per year · OWT
No recall names OWT since 2007.
Adverse event reports per year · OWT
82in 2025
MAUDE reports naming product code OWT, 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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 31 |
| 2019 | 2 | — | 0 | 61 |
| 2020 | 1 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 76 |
| 2024 | 1 | — | 0 | 65 |
| 2025 | 1 | — | 0 | 82 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
TephaFLEX® Composite Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hemia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: repair of colon and rectal prolapse (excluding rectocele) using an abdominal approach, sacral…
Read the full statement (110 words)
TephaFLEX® Composite Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hemia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: repair of colon and rectal prolapse (excluding rectocele) using an abdominal approach, sacral colposuspension and reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapsed). The film side of the device may help minimize the potential for tissue attachment to the mesh in case of direct contact with the viscera.
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/K101287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101287: Tephaflex Composite Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101287
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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