# K110604: VBB System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: Dec 13, 2011 after 285 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: 5 generations back to K001134 (2000). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020, Care Fusion (2010) Summary page 1.
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) 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.
- K090211: Inflatable Bone Tamp, Cardinal Health, Inc. (2009) Summary page 1.
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx, Boston Scientific Corp (2005)
- K080982: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters, Boston Scientific Corp (2008) Summary page 1.
- K992739: Click'x, Synthes Spine (2000) Summary page 1.

## Most influential descendants
- K130146: Synthes Synflate Vertevral Balloon System (2013), 0 descendants of its own

## Recalls of this device
- Oct 6, 2014 · Class II · Z-0877-2015: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

## Indications for use
The Vertebral Body Balloon 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/K110604
Methodology: https://510kreport.com/methodology