# K020110: Modification to Trelex Mesh Surgical Mesh

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific
- Decided: Apr 3, 2002 after 82 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: 1 generation back to K945377 (1994). 4 ancestors in all.
38 later devices descend from it; 6 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974098: Pubouurethral Sling, ETHICON, Inc. (1998) Summary page 1.
- K945377: Trelex Natural (R) Mesh, Meadox Medicals, Div. Boston Scientific Corp. (1994) Summary page 1.
- K010533: Biosling - Bioabsorbable Polymer Sling & Surgical Mesh, Injectx, Inc. (2001) Summary page 1.
- K980483: Mentor Suspend Sling, Mentor Corp. (1998) Summary page 1.

## Most influential descendants
- K041632: Minimesh Polypropylene Mesh (2004), 27 descendants of its own
- K053361: Modification to: Minimesh Polypropylene Mesh (2006), 16 descendants of its own
- K092207: Restorelle Polypropylene Mesh (2009), 13 descendants of its own
- K090739: Bard Sacrocolpopexy Graft (2009), 9 descendants of its own
- K101722: Alyte Y-Mesh Graft (2011), 8 descendants of its own

## Indications for use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K020110
Methodology: https://510kreport.com/methodology