# K152557: Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

- Pathway: 510(k) (Traditional)
- Applicant: G21, S.R.L.
- Decided: Feb 23, 2016 after 168 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: 7 generations back to K981251 (1998). 11 ancestors in all.
2 later devices descend 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)
- K130430: Ivas 10MM and 15MM Balloon Catheter, Stryker Corporation (2013) Summary page 5.
- K123942: Stryker Ivas Balloon Catheter, Stryker Corporation (2013) Summary page 5.
- K113154: Ivas Balloon Catheter, Stryker Corporation (2012) Summary page 5.
- K113477: Ivas 20MM (10 Gauge) Balloon Catheter, Stryker Instruments, Instruments Div. (2012) Summary page 5.
- K103807: Ivas 2-10MM (10 Guage) Ballon Catheter, Stryker Corporation (2011) Summary page 5.
- K093419: Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas 3-10MM (8 Gauge)Balloon Catheter, Ivas, Stryker Instruments, Instruments Div. (2010) Summary page 5.
- K110998: Affirm (TM) VCF System, Algea Therapies (2011) Summary page 5.

## Most influential descendants
- K172214: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (2017), 1 descendant of its own
- K200763: Osteo-site Vertebral Balloon (2020), 0 descendants of its own

## Indications for use
The 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 percutancous 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/K152557
Methodology: https://510kreport.com/methodology