# K111593: Guardian Inflatable Bone Expander System

- Pathway: 510(k) (Traditional)
- Applicant: Bm Korea Co., Ltd.
- Decided: Nov 18, 2011 after 164 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.
2 later devices descend 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)
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 1.
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 1.

## Most influential descendants
- K143006: GUARDIAN-SG Inflatable Bone Expander System (2015), 1 descendant of its own
- K162283: DCM Kyphoplasty System (2017), 0 descendants of its own

## Indications for use
The GUARDIAN Inflatable Bone Expander 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. 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/K111593
Methodology: https://510kreport.com/methodology