# K202027: Balex bone Expander System

- Pathway: 510(k) (Traditional)
- Applicant: Taeyeon Medical Co., Ltd.
- Decided: Feb 3, 2021 after 196 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: 4 generations back to K981251 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 4.
- K133669: Medinaut Kyphoplasty System, Imedicom (2014) Summary page 4.

## Most influential descendants
- K221142: Kyphoplasty Balloon System (2023), 0 descendants of its own

## Indications for use
The Balex Bone Expander System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

Source page: https://510kreport.com/device/K202027
Methodology: https://510kreport.com/methodology