510(k) · Cleared
ClearedAdvantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Cleared on Dec 20, 2017 as substantially equivalent to K020110 (Boston Scientific, 2002) and 2 other predicates after a 117-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Dec 20, 2017
- Review
- 117 days
- Class
- Class II
- Product code
- PWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K011251 (2001). 16 ancestors in all, the oldest K945377 (1994). No later device cites it as a predicate yet.
- Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 5 generations between
- 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- 1 generation backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
- This deviceK172565 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device…Boston Scientific Corporation · 2017
Show all 9 generations
- Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 8 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 6 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 5 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
- 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- 1 generation backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
- This deviceK172565 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device…Boston Scientific Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −8 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −7 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −6 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −5 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −4 | K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | 2007 | — |
| −3 | K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2007 | — |
| −2 | K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2008 | — |
| −1 | K081275 | Boston Scientific Surgical Mesh | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery… | Boston Scientific Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 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 PWJ? 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? (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 |
|---|---|---|---|
| * | K020110 | Modification to Trelex Mesh Surgical MeshSummary page 6…Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: OTN Premarket Notification: Boston Scientific, K020110 Trade name: Solyx™ SIS System Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Cl… | 2002 |
| * | K081275 | Boston Scientific Surgical MeshSummary page 6…Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: PAH Premarket Notification: Boston Scientific, K081275 Trade name: Obtryx™ II System (Curved & Halo) Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Cl… | 2008 |
| * | K121754 | Blue Sui SlingSummary page 6…Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: OTN Premarket Notification: Boston Scientific, K121754 The predicate devices have not been subject to a design-related recall. F. Device Description The subject devices are no… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 1 of the 16 ancestors has a recall of any class.
- 5 other devices also cite its predicate K020110.
How does its category compare?
All PWJ devicesPWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PWJ
4in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PWJ
259in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PWJ
No recall names PWJ since 2007.
Adverse event reports per year · PWJ
2in 2025
MAUDE reports naming product code PWJ, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 259 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures. The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures. The Lynx System Delivery Device is intended for use as an aid in insertion, placement…
Read the full statement (207 words)
The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.
The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.
The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.
The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.
The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172565: Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172565
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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