# K122459: Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Corporation
- Decided: Dec 13, 2012 after 122 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931386 (1993). 39 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103426: Lite Pelvic Floor Repair Kits, Boston Scientific Corp (2011) Summary page 1.

## Most influential descendants
- K172060: Capio SLIM Suture Capturing Device (2017), 1 descendant of its own
- K173527: Digitex Delivery Device (2018), 0 descendants of its own

## Recalls of this device
- Feb 12, 2018 · Class II · Z-1623-2018: Potential for Capio sutures to break and /or detach.
- Feb 12, 2018 · Class II · Z-1622-2018: Potential for Capio sutures to break and /or detach.

## Indications for use
The Pinnacle LITE Pelvic Floor Repair Kit is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior vaginal vault prolapse. The Uphold LITE Vaginal Support System is indicated for tissue reinforcement in women with pelvic organ prolapse, for the transvaginal repair of anterior and apical vaginal wall prolapse.

Source page: https://510kreport.com/device/K122459
Methodology: https://510kreport.com/methodology