# K153296: MEDINAUT Kyphoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Imedicom Co., Ltd.
- Decided: Jul 29, 2016 after 259 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: 4 generations back to K981251 (1998). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K192335: TRACKER Kyphoplasty System (2019), 1 descendant of its own
- K232842: Balloon Inflation System (2024), 0 descendants of its own
- K211797: TRACKER Plus Kyphoplasty System (2021), 0 descendants of its own
- K172871: SpineKure Kyphoplasty System (2018), 0 descendants of its own

## Indications for use
The MEDINAUT 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 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/K153296
Methodology: https://510kreport.com/methodology