# K071957: Pinnacle Pelvic Floor Repair Kits

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Corp
- Decided: Nov 8, 2007 after 115 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051245 (2005). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051245: Polyform Synthetic Mesh, Proxy Biomedical, Ltd. (2005) Summary page 1.

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

## Recalls of this device
- Feb 12, 2018 · Class II · Z-1625-2018: Potential for Capio sutures to break and /or detach.
- Feb 12, 2018 · Class II · Z-1624-2018: 
- May 10, 2011 · Not classified · Z-2931-2011: The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.

## Indications for use
The Pinnacle™ 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/K071957
Methodology: https://510kreport.com/methodology