# K100404: Ascendx VCF Reduction System

- Pathway: 510(k) (Traditional)
- Applicant: Aoi Medical, Inc.
- Decided: Dec 14, 2012 after 1,032 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kyphon, Inc.'s Kyphx Inflatable Bone Tamp: named in the summary without a submission number

## Most influential descendants
- K130089: Crosstrees Pva Pod (2013), 1 descendant of its own
- K133372: Crosstrees Pva Pod (2013), 0 descendants of its own

## Indications for use
The AscendXTM VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.

Source page: https://510kreport.com/device/K100404
Methodology: https://510kreport.com/methodology