# K123942: Stryker Ivas Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Apr 3, 2013 after 104 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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). 8 ancestors in all.
5 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)
- 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.
- K110998: Affirm (TM) VCF System, Algea Therapies (2011)
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 2.

## 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-1253-2018: 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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma.

Source page: https://510kreport.com/device/K123942
Methodology: https://510kreport.com/methodology