510(k) · Cleared
ClearedGynecare Prolift +M* Pelvic Floor Repair Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on May 15, 2008 as substantially equivalent to K013718 (Gynecare, A Div. of Ethicon, Inc., 2002) and 3 other predicates after a 346-day review. Its family tree reaches back 9 generations to 1993. 20 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 346 days
- Class
- Class III
- Product code
- OTP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K931386 (1993). 24 ancestors in all, the oldest K922916 (1992). 20 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 5 generations between
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 1 generation backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- This deviceK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- Descendant · cites it directly · 13 of its ownK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
- Descendant · cites it directly · 6 of its ownK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · Recalled
- Descendant · 2 generations on · 5 of its ownK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
- Descendant · 2 generations on · 4 of its ownK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
Show all 9 generations
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 7 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 6 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 5 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 4 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 1 generation backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- This deviceK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009 · cites it directly13descendants
- K112322Restorelle Polypropylene Y MeshColoplast A/S · 2012 · 2 generations on6descendants
- K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · cites it directly6descendants
- K091131Pelvic Floor Repair SystemBoston Scientific · 2009 · 2 generations on5descendants
- K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −8 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −7 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −6 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −5 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −4 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −3 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −2 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −1 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| +1 | K092207 | Restorelle Polypropylene Mesh | Mpathy Medical Devices, Inc. | 2009 | — |
| +2 | K112322 | Restorelle Polypropylene Y Mesh | Coloplast A/S | 2012 | — |
| +1 | K081048 | Pinnacle Pelvic Floor Repair Kit II | Boston Scientific Corp | 2008 | 1 |
| +2 | K091131 | Pelvic Floor Repair System | Boston Scientific | 2009 | — |
| +2 | K103426 | Lite Pelvic Floor Repair Kits | Boston Scientific Corp | 2011 | — |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 OTP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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…r Systems GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems Predicate Devices: GYNECARE GYNEMESH PS* PROLENE* Soft Mesh (ETHICON, Inc.) - K013718 ULTRAPRO* Mesh (ETHICON, Inc.) — K033337 AMS APOGEE Vault Suspension System (American Medical Systems, Inc.) - K040537 AMS PERIG… | 2002 |
| * | K033337 | Ultrapro MeshSummary page 1…erior, and Posterior Pelvic Floor Repair Systems Predicate Devices: GYNECARE GYNEMESH PS* PROLENE* Soft Mesh (ETHICON, Inc.) - K013718 ULTRAPRO* Mesh (ETHICON, Inc.) — K033337 AMS APOGEE Vault Suspension System (American Medical Systems, Inc.) - K040537 AMS PERIGEE System (American Medical Systems, Inc.… | 2004 |
| * | K040537 | Ams Apogee Vault Suspension SystemSummary page 1…GYNEMESH PS* PROLENE* Soft Mesh (ETHICON, Inc.) - K013718 ULTRAPRO* Mesh (ETHICON, Inc.) — K033337 AMS APOGEE Vault Suspension System (American Medical Systems, Inc.) - K040537 AMS PERIGEE System (American Medical Systems, Inc.) — K040623 e o o o Statement of Intended Use: The GYNECARE PROLIFT* Total,… | 2004 |
| * | K040623 | Ams Perigee SystemSummary page 1…APRO* Mesh (ETHICON, Inc.) — K033337 AMS APOGEE Vault Suspension System (American Medical Systems, Inc.) - K040537 AMS PERIGEE System (American Medical Systems, Inc.) — K040623 e o o o Statement of Intended Use: The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through t… | 2004 |
What descends from it? (20)
See all 205 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?
- 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 24 ancestors have a recall of any class.
- Of its descendants, K092207 (Mpathy Medical Devices, Inc., 2009) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K013718.
How does its category compare?
All OTP devicesOTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OTP
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OTP
71in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTP
No recall names OTP since 2007.
Adverse event reports per year · OTP
26in 2025
MAUDE reports naming product code OTP, 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 | 4 | 90 | 0 | 1 |
| 2008 | 8 | 103 | 0 | 0 |
| 2009 | 6 | 21 | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 5 | 71 | 0 | 32 |
| 2012 | 2 | — | 0 | 494 |
| 2013 | 0 | — | 0 | 7,150 |
| 2014 | 0 | — | 0 | 778 |
| 2015 | 0 | — | 0 | 684 |
| 2016 | 0 | — | 0 | 415 |
| 2017 | 0 | — | 0 | 273 |
| 2018 | 0 | — | 0 | 392 |
| 2019 | 0 | — | 0 | 368 |
| 2020 | 0 | — | 0 | 175 |
| 2021 | 0 | — | 0 | 647 |
| 2022 | 0 | — | 0 | 114 |
| 2023 | 0 | — | 0 | 59 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems are 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. The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH…
Read the full statement (102 words)
The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems are 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.
The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071512 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071512
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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