# K051245: Polyform Synthetic Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Proxy Biomedical, Ltd.
- Decided: Jun 17, 2005 after 32 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mersilene Mesh: named in the summary without a submission number
- (no number) Prolene Soft Mesh: named in the summary without a submission number
- (no number) Bard Mesh: named in the summary without a submission number

## Most influential descendants
- K071957: Pinnacle Pelvic Floor Repair Kits (2007), 7 descendants of its own
- K081048: Pinnacle Pelvic Floor Repair Kit II (2008), 6 descendants of its own
- K091131: Pelvic Floor Repair System (2009), 5 descendants of its own
- K103426: Lite Pelvic Floor Repair Kits (2011), 4 descendants of its own
- K122459: Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System (2012), 2 descendants of its own

## 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/K051245
Methodology: https://510kreport.com/methodology