# K223709: Kyphoplasty Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Changmei Medtech Co., Ltd.
- Decided: Aug 16, 2023 after 247 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: 10 generations back to K981251 (1998). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192449: Joline Kyphoplasty System Allevo, Joline GmbH & Co. KG (2020) Summary page 4.

## Most influential descendants
- K260203: Fule Vertebroplasty Balloon Catheter (2026), 0 descendants of its own
- K252458: Kyphoplasty Balloon Dilatation Catheters (2025), 0 descendants of its own

## Indications for use
Kyphoplasty Balloon Catheter is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

Source page: https://510kreport.com/device/K223709
Methodology: https://510kreport.com/methodology