510(k) · Cleared
ClearedAms Pelvic Floor Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Aug 3, 2005 as substantially equivalent to K040537 (American Medical Systems, Inc., 2004) and 6 other predicates after a 58-day review. Its family tree reaches back 10 generations to 1993. 17 later devices descend from it.
- Decided
- Aug 3, 2005
- Review
- 58 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K931386 (1993). 38 ancestors in all, the oldest K830889 (1983). 17 later devices descend from it, 5 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 backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- This deviceK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- Descendant · 4 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 5 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
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 backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- This deviceK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc. · 2008 · cites it directly11descendants
- K090288Orthadapt PRPegasus Biologics, Inc. · 2009 · 2 generations on7descendants
- K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011 · 3 generations on5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 4 generations on4descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 5 generations on2descendants
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 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| 0 (this device) | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| +1 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
| +2 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| +3 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| +4 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +5 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 OTO? 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? (7)
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 |
|---|---|---|---|
| * | K040537 | Ams Apogee Vault Suspension SystemSummary page 1…e: QTO, O Classification: Clas;rll ' TP Manufacturing Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Apogee — K040537 AMS Perigee — K040623 AMS Pre-Connected Apogee, Perigee, & BioArc — K050445 AMS Porcine Dermis — K050445 AMS Sparc Sling System -… | 2004 |
| * | K040623 | Ams Perigee SystemSummary page 1…on: Clas;rll ' TP Manufacturing Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Apogee — K040537 AMS Perigee — K040623 AMS Pre-Connected Apogee, Perigee, & BioArc — K050445 AMS Porcine Dermis — K050445 AMS Sparc Sling System -K021263 AMS Monarc Sli… | 2004 |
| * | K050445 | Ams Collagen Dermal Matrix Cleared while this submission was under review Summary page 1…dical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Apogee — K040537 AMS Perigee — K040623 AMS Pre-Connected Apogee, Perigee, & BioArc — K050445 AMS Porcine Dermis — K050445 AMS Sparc Sling System -K021263 AMS Monarc Sling System — K023516 AMS Silicone-Coated Sling and Surg… | 2005 |
| * | K021263 | Modification to Sparc Sling SystemSummary page 1…Predicate Devices: AMS Apogee — K040537 AMS Perigee — K040623 AMS Pre-Connected Apogee, Perigee, & BioArc — K050445 AMS Porcine Dermis — K050445 AMS Sparc Sling System -K021263 AMS Monarc Sling System — K023516 AMS Silicone-Coated Sling and Surgical Mesh — K002721 AMS Large Pore Polypropylene Mesh — K0405… | 2002 |
| * | K023516 | Monarc Sling SystemSummary page 1…040537 AMS Perigee — K040623 AMS Pre-Connected Apogee, Perigee, & BioArc — K050445 AMS Porcine Dermis — K050445 AMS Sparc Sling System -K021263 AMS Monarc Sling System — K023516 AMS Silicone-Coated Sling and Surgical Mesh — K002721 AMS Large Pore Polypropylene Mesh — K040521 Indications for Use: The AMS P… | 2002 |
| * | K002721 | Ams Triangle Silicone-Coated Sling and Surgical MeshSummary page 1…Perigee, & BioArc — K050445 AMS Porcine Dermis — K050445 AMS Sparc Sling System -K021263 AMS Monarc Sling System — K023516 AMS Silicone-Coated Sling and Surgical Mesh — K002721 AMS Large Pore Polypropylene Mesh — K040521 Indications for Use: The AMS Pelvic Floor Repair System is intended for use where th… | 2000 |
| * | K040521 | Modification to Ams Large Pore Polypropylene MeshSummary page 1…mis — K050445 AMS Sparc Sling System -K021263 AMS Monarc Sling System — K023516 AMS Silicone-Coated Sling and Surgical Mesh — K002721 AMS Large Pore Polypropylene Mesh — K040521 Indications for Use: The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for impl… | 2004 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP… | 2008 | 11 |
| K082677 | Ams Elevate Anterior & Apical Prolapse Repair System with Intepro Lite | 2008 | 1 |
| K070993 | Topas System | 2007 | 1 |
| K082387 | Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic… | 2008 | 0 |
| K081710 | Apogee and Perigee Systems with PC Coated Intepro Lite | 2008 | 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 12 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 4 of the 38 ancestors have a recall of any class.
- Of its descendants, K080185 (American Medical Systems, Inc., 2008) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K040537.
How does its category compare?
All OTO devicesOTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OTO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OTO
95in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTO
No recall names OTO since 2007.
Adverse event reports per year · OTO
79in 2025
MAUDE reports naming product code OTO, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 7 | 101 | 0 | 160 |
| 2013 | 4 | 95 | 0 | 2,272 |
| 2014 | 1 | — | 0 | 267 |
| 2015 | 2 | — | 0 | 448 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 0 | — | 0 | 145 |
| 2019 | 0 | — | 0 | 347 |
| 2020 | 0 | — | 0 | 153 |
| 2021 | 0 | — | 0 | 292 |
| 2022 | 0 | — | 0 | 112 |
| 2023 | 0 | — | 0 | 101 |
| 2024 | 0 | — | 0 | 113 |
| 2025 | 0 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
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/K051485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051485: Ams Pelvic Floor Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051485
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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