# K172214: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

- Pathway: 510(k) (Special)
- Applicant: G-21 S.R.L.
- Decided: Aug 23, 2017 after 30 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K981251 (1998). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152557: Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters, G21, S.R.L. (2016) Summary page 5.

## Most influential descendants
- K200763: Osteo-site Vertebral Balloon (2020), 0 descendants of its own

## Indications for use
The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Source page: https://510kreport.com/device/K172214
Methodology: https://510kreport.com/methodology