# K192335: TRACKER Kyphoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Dec 4, 2019 after 98 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153296: MEDINAUT Kyphoplasty System, Imedicom Co., Ltd. (2016) Summary page 4.
- K133669: Medinaut Kyphoplasty System, Imedicom (2014) Summary page 4.

## Most influential descendants
- K211797: TRACKER Plus Kyphoplasty System (2021), 0 descendants of its own

## Indications for use
The TRACKER Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes use during percutaneous vertebral augmentation. This 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/K192335
Methodology: https://510kreport.com/methodology