# K133669: Medinaut Kyphoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Imedicom
- Decided: Apr 4, 2014 after 126 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: 3 generations back to K981251 (1998). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 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 1.
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A, Kyphon, Inc. (2001) Summary page 2.
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 1.

## Most influential descendants
- K153296: MEDINAUT Kyphoplasty System (2016), 4 descendants of its own
- K202027: Balex bone Expander System (2021), 1 descendant of its own
- K192335: TRACKER Kyphoplasty System (2019), 1 descendant of its own
- K232842: Balloon Inflation System (2024), 0 descendants of its own
- K221142: Kyphoplasty Balloon System (2023), 0 descendants of its own

## Indications for use
The MEDINAUT Kyphoplasty System 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. 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/K133669
Methodology: https://510kreport.com/methodology