510(k) Report

510(k) · Cleared

Cleared

Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996

K040538510(k) SpecialCleared Mar 17, 200415-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

American Medical Systems, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Mar 17, 2004 as substantially equivalent to K030123 (American Medical Systems, Inc., 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 2001. 39 later devices descend from it.

Decided
Mar 17, 2004
Review
15 days
Class
Class II
Product code
OTN
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K011251 (2001). 6 ancestors in all. 39 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2005: 3 descendants cleared2004: 1 descendant cleared2008: 7 descendants cleared2006: 1 descendant cleared2007: 1 descendant cleared2016: 2 descendants cleared2012: 3 descendants cleared2013: 3 descendants cleared2009: 2 descendants cleared2011: 2 descendants cleared2019: 1 descendant cleared2022: 4 descendants cleared2023: 2 descendants cleared2025: 3 descendants cleared2026: 3 descendants cleared2024: 1 descendant cleared×2: 2 generations cleared close together, K011251 (2001), K013355 (2001) ×2: 2 generations cleared close together, K020663 (2002), K021263 (2002) K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 6 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalledK021263 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K020663 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001K011251 · Sparc Sling System · American Medical Systems, Inc. · 2001−50+5
  1. Root · 5 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 4 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 3 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 2 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. 1 generation backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. This deviceK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
  7. Descendant · cites it directly · 37 of its ownK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
  8. Descendant · cites it directly · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
  9. Descendant · 2 generations on · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
  10. Descendant · 2 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
  11. Descendant · 3 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 12007: 12008: 72009: 22011: 22012: 32013: 32016: 22019: 12022: 42023: 22024: 12025: 32026: 3
2004high 7 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 39 · See all
  • K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004 · cites it directly37descendants
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · cites it directly30descendants
  • K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · 2 generations on17descendants
  • K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 2 generations on12descendants
  • K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−4K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−3K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−2K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−1K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
0 (this device)K040538Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc.2004—
+1K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc.2004—
+1K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.20051
+2K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.2005—
+2K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal…American Medical Systems, Inc.2008—
+3K120019Collagen RibbonWrightmedicaltechnologyinc2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200610
200710
200870
200920
201120
201230
201330
201620
201910
202240
202320
202410
202530
202630
FIG. 1 — Lineage of K040538, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OTN? 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 OTN device

  1. #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K030123Bioarc SP Sling Kit
Summary page 1
…ethral Sling, Surgical Mesh Device Trade Name: BioArc TO™ Subfascial Hammock Device Classification Name: Surgical Mesh, polymeric Predicate Device: BioArc SP™ Sling Kit, K030123 MONARC™ subfascial hammock, K023516 Device Description: The BioArc TO Subfascial Hammock is a suburethral sling procedure that…
American Medical Systems, Inc.2003—
*K023516Monarc Sling System
Summary page 1
…ade Name: BioArc TO™ Subfascial Hammock Device Classification Name: Surgical Mesh, polymeric Predicate Device: BioArc SP™ Sling Kit, K030123 MONARC™ subfascial hammock, K023516 Device Description: The BioArc TO Subfascial Hammock is a suburethral sling procedure that uses a transobturator surgical appro…
American Medical Systems, Inc.20021

Also cleared against K030123: 3 other devices →

What descends from it? (39)

See all 39

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc.200437
K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.200530
K051530Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195.American Medical Systems, Inc.20056

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 3 years and passes through 1 company; a new generation was cleared every 5 months on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K041948 (American Medical Systems, Inc., 2004) has gone furthest, with 37 descendants of its own.
  • 3 other devices also cite its predicate K030123.

How does its category compare?

All OTN devices

OTN Mesh, Surgical, 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 · OTN

1in 2023

2007: 22008: 32009: 22010: 52011: 42012: 12013: 52014: 12017: 12019: 12020: 12021: 32022: 22023: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTN

89in 2021

2008: 100 days median2010: 25 days median2011: 56 days median2013: 86 days median2021: 89 days median
2007high 100 (2008) · low 25 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OTN

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OTN

458in 2025

2010: 12011: 252012: 8742013: 19,0842014: 2,0632015: 3,9042016: 1,9022017: 6762018: 7372019: 2,4572020: 1,0032021: 2,6062022: 8092023: 1,0762024: 8222025: 458
2007high 19,084 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
2008310000
20092—00
201052501
2011456025
20121—0874
2013586019,084
20141—12,063
20150—03,904
20160—01,902
20171—0676
20180—0737
20191—02,457
20201—01,003
202138902,606
20222—0809
20231—01,076
20240—0822
20250—0458
20261—0—

What is it indicated for?

The BioAre SP Sling Kit is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / 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.

Also cleared against K030123

3 other devices cite the same predicate.

  • K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
  • K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  • K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004

More from American Medical Systems, Inc.

75 FDA decisions under this applicant name. See the company

  • K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
  • K112842Ams Elevate PCAmerican Medical Systems, Inc. · 2011
  • K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
  • K092735Greenlight XPS Laser SystemAmerican Medical Systems, Inc. · 20091 recall
  • K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2009

Recent decisions in OTN

The OTN category page

  • K262284Kim BlueDesarrollo e Investigación Médica Aragonesa S.L. · 2026
  • K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2023
  • K222293ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
  • K222468ArcTO Transobturator Sling SystemUrocure, LLC · 2022
  • K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc. · 2021

https://510kreport.com/device/K040538 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040538: Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040538

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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