# K211223: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jul 21, 2021 after 89 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: 4 generations back to K945377 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020110: Modification to Trelex Mesh Surgical Mesh, Boston Scientific (2002) Summary page 6.
- K121754: Blue Sui Sling, Boston Scientific Corp (2012) Summary page 6.

## Most influential descendants
- K231549: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K211223
Methodology: https://510kreport.com/methodology