510(k) · Cleared
ClearedTBD Ethicon Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Sep 5, 2008 as substantially equivalent to K013718 (Gynecare, A Div. of Ethicon, Inc., 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 10 generations to 1993. 1 later device descends from it.
- Decided
- Sep 5, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931386 (1993). 25 ancestors in all, the oldest K922916 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations between
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- This deviceK082216 TBD Ethicon MeshETHICON, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK113205 Artisyn Y-Shaped MeshETHICON, Inc. · 2012
Show all 10 generations
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 5 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 4 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- This deviceK082216 TBD Ethicon MeshETHICON, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K113205Artisyn Y-Shaped MeshETHICON, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −9 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −8 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −7 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −6 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −5 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −4 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −3 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −2 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −1 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| 0 (this device) | K082216 | TBD Ethicon Mesh | ETHICON, Inc. | 2008 | — |
| +1 | K113205 | Artisyn Y-Shaped Mesh | ETHICON, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K013718 | Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic…Summary page 1…CFR § 878.3300, Surgical Mesh (FTL) Trade Name: ETHICON Mesh (TBD) Predicate Devices: · GYNECARE GYNEMESH® PS PROLENE® Soft Mesh (ETHICON, Inc.) - K013718 · GYNECARE PROLIFT+MTM Pelvic Floor Repair Systems (ETHICON, Inc.) - K071512 Statement of Intended Use: ET… | 2002 |
| * | K071512 | Gynecare Prolift +M* Pelvic Floor Repair SystemsSummary page 1…Devices: · GYNECARE GYNEMESH® PS PROLENE® Soft Mesh (ETHICON, Inc.) - K013718 · GYNECARE PROLIFT+MTM Pelvic Floor Repair Systems (ETHICON, Inc.) - K071512 Statement of Intended Use: ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fasci… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113205 | Artisyn Y-Shaped Mesh | 2012 | 0 |
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?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K113205 (ETHICON, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K013718.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
ETHICON MESH is indicated for tissue reinforcement and long lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082216: TBD Ethicon Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082216
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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