# K103064: Avamax Vertebral Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Jan 10, 2011 after 84 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: 3 generations back to K981251 (1998). 6 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Cited in the summary but kept off the family tree
- K093643: Multi- Unit Abutments for Straumann and Astra Tech Implant Systems, Nobel Biocare AB (2010). Our reading of the summary gave K093643, FDA’s number for Multi- Unit Abutments for Straumann and Astra Tech Implant… (Nobel Biocare AB). Its FDA name has none of the distinctive words the summary uses for the device it names, “CareFusion Inflatable Bone Tamp”. Kept off the family tree. Summary page 2.

## 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 and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

Source page: https://510kreport.com/device/K103064
Methodology: https://510kreport.com/methodology