# K113477: Ivas 20MM (10 Gauge) Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments, Instruments Div.
- Decided: Jan 6, 2012 after 44 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: 5 generations back to K981251 (1998). 6 ancestors in all.
7 later devices descend from it; 3 cite 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)
- K103807: Ivas 2-10MM (10 Guage) Ballon Catheter, Stryker Corporation (2011) Summary page 1.
- 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 1.
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 1.

## Most influential descendants
- K130430: Ivas 10MM and 15MM Balloon Catheter (2013), 5 descendants of its own
- K123942: Stryker Ivas Balloon Catheter (2013), 5 descendants of its own
- K152557: Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (2016), 2 descendants of its own
- K172116: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (2018), 1 descendant of its own
- K172214: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (2017), 1 descendant of its own

## Indications for use
The Stryker@ VAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Poly methylniethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Source page: https://510kreport.com/device/K113477
Methodology: https://510kreport.com/methodology