# K221142: Kyphoplasty Balloon System

- Pathway: 510(k) (Traditional)
- Applicant: OK Medinet Korea Co., Ltd.
- Decided: Apr 21, 2023 after 367 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: 5 generations back to K981251 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202027: Balex bone Expander System, Taeyeon Medical Co., Ltd. (2021) Summary page 4.

## Indications for use
The Kyphoplasty Balloon System (KYBS) is intended to be used for the reduction and fixation 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, such as kyphoplasty.

Source page: https://510kreport.com/device/K221142
Methodology: https://510kreport.com/methodology