# K081048: Pinnacle Pelvic Floor Repair Kit II

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Corp
- Decided: Aug 22, 2008 after 130 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931386 (1993). 27 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 34 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) Summary page 1.
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems, ETHICON, Inc. (2008). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- 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-1626-2018: Potential for Capio sutures to break and /or detach.

## Indications for use
The proposed Pinnacle Pelvic Floor Repair Kit is 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/K081048
Methodology: https://510kreport.com/methodology