510(k) · Cleared
Recalled · 2008Ams Collagen Dermal Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Jun 17, 2005 as substantially equivalent to K021160 (Carbon Medical Technologies, Inc., 2002) and 5 other predicates after a 115-day review. Its family tree reaches back 9 generations to 1993. 30 later devices descend from it. It has been recalled once.
- Decided
- Jun 17, 2005
- Review
- 115 days
- Class
- Class II
- Product code
- PAG
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 9 generations to K931386 (1993). 37 ancestors in all, the oldest K830889 (1983). 30 later devices descend from it, 3 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 deviceK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005
- Descendant · cites it directly · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- Descendant · cites it directly · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- Descendant · 2 generations on · 11 of its ownK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 10 of its ownK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
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 deviceK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · cites it directly17descendants
- K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · cites it directly12descendants
- K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 2 generations on11descendants
- K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc. · 2008 · 2 generations on11descendants
- K131143Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013 · 3 generations on10descendants
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) | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | — |
| +1 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| +1 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| +2 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| +2 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
| +3 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 PAG? 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? (6)
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 |
|---|---|---|---|
| * | K021160 | Dermmatrix Surgical MeshSummary page 1…Manufacturing Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: For AMS Collagen Dermal Matrix : DermMatrix/InteXen ~ K021160 Surgisis Sling — K992159 - For AMS Bioarc SP & Bioarc TO with Pre-Connected Collagen Dermal Matrix : AMS Bioarc SP - K040538 AMS… | 2002 |
| * | K992159 | Surgisis SlingSummary page 1…merican Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: For AMS Collagen Dermal Matrix : DermMatrix/InteXen ~ K021160 Surgisis Sling — K992159 - For AMS Bioarc SP & Bioarc TO with Pre-Connected Collagen Dermal Matrix : AMS Bioarc SP - K040538 AMS Bioarc TO - K041948 For… | 1999 |
| * | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996Summary page 1…llagen Dermal Matrix : DermMatrix/InteXen ~ K021160 Surgisis Sling — K992159 - For AMS Bioarc SP & Bioarc TO with Pre-Connected Collagen Dermal Matrix : AMS Bioarc SP - K040538 AMS Bioarc TO - K041948 For AMS Perigee System with Pre-Connected Collagen Dermal Matrix : AMS Perigee System ~ K040623 For AMS… | 2004 |
| * | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsSummary page 1…ermMatrix/InteXen ~ K021160 Surgisis Sling — K992159 - For AMS Bioarc SP & Bioarc TO with Pre-Connected Collagen Dermal Matrix : AMS Bioarc SP - K040538 AMS Bioarc TO - K041948 For AMS Perigee System with Pre-Connected Collagen Dermal Matrix : AMS Perigee System ~ K040623 For AMS Apogee System with Pre-… | 2004 |
| * | K040623 | Ams Perigee SystemSummary page 1…nnected Collagen Dermal Matrix : AMS Bioarc SP - K040538 AMS Bioarc TO - K041948 For AMS Perigee System with Pre-Connected Collagen Dermal Matrix : AMS Perigee System ~ K040623 For AMS Apogee System with Pre-Connected Collagen Dermal Matrix : AMS Apogee System — K040537 Indications for Use: The AMS coll… | 2004 |
| * | K040537 | Ams Apogee Vault Suspension SystemSummary page 1…ee System with Pre-Connected Collagen Dermal Matrix : AMS Perigee System ~ K040623 For AMS Apogee System with Pre-Connected Collagen Dermal Matrix : AMS Apogee System — K040537 Indications for Use: The AMS collagen dermal matrix is intended for use in the treatment of hernias where the connective tissue… | 2004 |
What descends from it? (30)
See all 303 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2008 | Not classified | Z-0932-2009 | Labeling mix-ups | The product size shown on the carton labeling does not match the size on the product inside. |
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.
- 3 of the 37 ancestors have a recall of any class.
- Of its descendants, K051485 (American Medical Systems, Inc., 2005) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K021160.
How does its category compare?
All PAG devicesPAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PAG
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · PAG
Too few PAG 510(k)s in any year since 2007 to give a median.
Recalls per year · PAG
No recall names PAG since 2007.
Adverse event reports per year · PAG
1in 2023
MAUDE reports naming product code PAG, 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 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 256 |
| 2015 | 0 | — | 0 | 73 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMS collagen dermal matrix is intended for use in the treatment of hemias 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 fimited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the…
Read the full statement (107 words)
The AMS collagen dermal matrix is intended for use in the treatment of hemias 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 fimited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypemmobility or intrinsic sphincter deficiency.
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/K050445 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050445: Ams Collagen Dermal Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050445
Report an extraction error
Are you the manufacturer?
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