# K200763: Osteo-site Vertebral Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Izi Medical
- Decided: Aug 12, 2020 after 141 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: 9 generations back to K981251 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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 4.
- K172214: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters, G-21 S.R.L. (2017) Summary page 4.

## Indications for use
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.

Source page: https://510kreport.com/device/K200763
Methodology: https://510kreport.com/methodology