# K053414: Mentor Novasilk Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Dec 27, 2005 after 20 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- 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 K013718 (2002). 1 ancestor in all.
8 later devices descend from it; 3 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)
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair, Gynecare, A Div. of Ethicon, Inc. (2002)

## Most influential descendants
- 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
- K172060: Capio SLIM Suture Capturing Device (2017), 1 descendant of its own
- K083499: Exair Anterior and Posterior Prolapse Repair Systems (2009), 1 descendant of its own
- K173527: Digitex Delivery Device (2018), 0 descendants of its own

## Indications for use
The Mentor NovaSilk Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Source page: https://510kreport.com/device/K053414
Methodology: https://510kreport.com/methodology