# K171271: Polyform Synthetic Mesh

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Dec 15, 2017 after 228 days
- Product code: OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed)
- 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 K051245 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051245: Polyform Synthetic Mesh, Proxy Biomedical, Ltd. (2005) Summary page 4.

## Indications for use
Polyform Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Source page: https://510kreport.com/device/K171271
Methodology: https://510kreport.com/methodology