510(k) · Cleared
Recalled · 2012Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · FTL Mesh, Surgical, Polymeric
Cleared on Dec 22, 2010 as substantially equivalent to K092207 (Mpathy Medical Devices, Inc., 2009) and 2 other predicates after a 16-day review. Its family tree reaches back 11 generations to 1993. It has been recalled once.
- Decided
- Dec 22, 2010
- Review
- 16 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K931386 (1993). 33 ancestors in all, the oldest K905655 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations between
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 1 generation backK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
- This deviceK103568 Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S · 2010
Show all 11 generations
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 6 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 5 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 4 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 1 generation backK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
- This deviceK103568 Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −10 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −9 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −8 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −7 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −6 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −5 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −4 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −3 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −2 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| −1 | K092207 | Restorelle Polypropylene Mesh | Mpathy Medical Devices, Inc. | 2009 | — |
| 0 (this device) | K103568 | Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh | Coloplast A/S | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K092207 | Restorelle Polypropylene MeshSummary page 1…Polymeric Surgical Mesh PROPRIETARY NAME RestorelleTM polypropylene mesh PREDICATE DEVICE a K092207 - Restorelle a K041632 &K053361 - Minimesh (Mpathy Medical Ltd) DEVICE DESCRIPTIO… | 2009 |
| * | K041632 | Minimesh Polypropylene MeshSummary page 1…RestorelleTM polypropylene mesh PREDICATE DEVICE a K092207 - Restorelle a K041632 &K053361 - Minimesh (Mpathy Medical Ltd) DEVICE DESCRIPTION Restorelle isanon-absorbable polypropyle… | 2004 |
| * | K053361 | Modification to: Minimesh Polypropylene MeshSummary page 1…RestorelleTM polypropylene mesh PREDICATE DEVICE a K092207 - Restorelle a K041632 &K053361 - Minimesh (Mpathy Medical Ltd) DEVICE DESCRIPTION Restorelle isanon-absorbable polypropylene mesh c… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 2, 2012 | Not classified | Z-1481-2012 | Error in labeling | Coloplast is conducting a field correction based on the conclusion that two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifically the patient label depicts the size… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 33 ancestors have a recall of any class.
- 3 other devices also cite its predicate K092207.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103568 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103568: Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103568
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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