# K103807: Ivas 2-10MM (10 Guage) Ballon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Jun 28, 2011 after 181 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: 4 generations back to K981251 (1998). 5 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K113477: Ivas 20MM (10 Gauge) Balloon Catheter (2012), 7 descendants of its own
- K130430: Ivas 10MM and 15MM Balloon Catheter (2013), 5 descendants of its own
- K123942: Stryker Ivas Balloon Catheter (2013), 5 descendants of its own
- K113154: Ivas Balloon Catheter (2012), 3 descendants of its own
- K152557: Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (2016), 2 descendants of its own

## Indications for use
The Stryker® IVAS 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 Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Source page: https://510kreport.com/device/K103807
Methodology: https://510kreport.com/methodology