# K162062: AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Nov 1, 2016 after 98 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: 7 generations back to K981251 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150523: AVAmax Vertebral Balloon, Care Fusion (2015) Summary page 5.
- K151125: AVAflex Vertebral Balloon System, Care Fusion (2015) Summary page 5.

## Indications for use
The AVAmax Vertebral Balloon System (system) is intended 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 and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. The AVAflex Vertebral Balloon System (system) is intended 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/K162062
Methodology: https://510kreport.com/methodology