# K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Feb 26, 2010 after 112 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). 7 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090211: Inflatable Bone Tamp, Cardinal Health, Inc. (2009) Summary page 1.
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 1.
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 1.
- K043518: Radiopaque Bone Cement, Cardinalhealth (2005) Summary page 1.

## Most influential descendants
- K131820: Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G (2013), 8 descendants of its own
- K122533: Osseoflex SB Inflatable Bone Tamp (2012), 8 descendants of its own
- K140937: Osseoflex SB (2014), 7 descendants of its own
- K141930: Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML (2014), 6 descendants of its own
- K151704: Diplomat® Spinal System (2016), 4 descendants of its own

## Indications for use
Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

Source page: https://510kreport.com/device/K093463
Methodology: https://510kreport.com/methodology