# K231549: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jun 29, 2023 after 30 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945377 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211223: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System, Boston Scientific Corporation (2021) Summary page 5.

## Indications for use
Advantage Ultra System and Advantage Fit Ultra System The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures. Lynx Ultra System The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

Source page: https://510kreport.com/device/K231549
Methodology: https://510kreport.com/methodology