# K252458: Kyphoplasty Balloon Dilatation Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Lange Medtech Co., Ltd.
- Decided: Nov 3, 2025 after 90 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: 11 generations back to K981251 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223709: Kyphoplasty Balloon Catheter, Jiangsu Changmei Medtech Co., Ltd. (2023) Summary page 7.

## Indications for use
Kyphoplasty Balloon Dilatation Catheters are 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 polymethylmethacrylate (PMMA) bone cements).

Source page: https://510kreport.com/device/K252458
Methodology: https://510kreport.com/methodology