# K131820: Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Oct 4, 2013 after 106 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981251 (1998). 9 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103064: Avamax Vertebral Balloon, Care Fusion (2011) Summary page 1.
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020, Care Fusion (2010) Summary page 1.
- K090211: Inflatable Bone Tamp, Cardinal Health, Inc. (2009) Summary page 1.
- K043518: Radiopaque Bone Cement, Cardinalhealth (2005) Summary page 1.

## Most influential descendants
- K151704: Diplomat® Spinal System (2016), 4 descendants of its own
- K191932: Momentum™ Posterior Spinal Fixation System (2019), 2 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own
- K150523: AVAmax Vertebral Balloon (2015), 1 descendant of its own
- K251719: Momentum® Posterior Spinal Fixation System (2025), 0 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/K131820
Methodology: https://510kreport.com/methodology