# K103426: Lite Pelvic Floor Repair Kits

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Corp
- Decided: Sep 14, 2011 after 296 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: 12 generations back to K931386 (1993). 38 ancestors in all.
4 later devices descend from it; 2 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)
- K071957: Pinnacle Pelvic Floor Repair Kits, Boston Scientific Corp (2007)
- K081048: Pinnacle Pelvic Floor Repair Kit II, Boston Scientific Corp (2008)
- K091131: Pelvic Floor Repair System, Boston Scientific (2009) Summary page 1.
- K053414: Mentor Novasilk Mesh, Mentor Corp. (2005) Summary page 1.
- K092207: Restorelle Polypropylene Mesh, Mpathy Medical Devices, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K173527: Digitex Delivery Device (2018), 0 descendants of its own
- K122794: Upsylon Y Mesh (2012), 0 descendants of its own

## Indications for use
The proposed LITE Pelvic Floor Repair Kits are indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for 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/K103426
Methodology: https://510kreport.com/methodology