# K130430: Ivas 10MM and 15MM Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: May 23, 2013 after 92 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981251 (1998). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113477: Ivas 20MM (10 Gauge) Balloon Catheter, Stryker Instruments, Instruments Div. (2012) Summary page 1.
- 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.
- (no number) Kyphx Xpander Inflatable Bone Tamp: named in the summary without a submission number

## Most influential descendants
- 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
- K200763: Osteo-site Vertebral Balloon (2020), 0 descendants of its own
- K181752: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (2018), 0 descendants of its own

## Recalls of this device
- Nov 9, 2017 · Class II · Z-1254-2018: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

## 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/K130430
Methodology: https://510kreport.com/methodology