# K151125: AVAflex Vertebral Balloon System

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Nov 24, 2015 after 210 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: 6 generations back to K981251 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131824: Avaflex Vertebral Balloon System, Care Fusion (2013) Summary page 4.
- K043518: Radiopaque Bone Cement, Cardinalhealth (2005) Summary page 4.

## Most influential descendants
- K162062: AVAmax Vertebral Balloon, AVAflex Vertebral Balloon (2016), 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/K151125
Methodology: https://510kreport.com/methodology