# K053336: Staxx FX System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jul 3, 2006 after 214 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: 8 generations back to K970097 (1997). 38 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 51 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 2.
- K040612: Sky Bone Expander System (Sky System), Disc-O-Tech Medical Technologies, Ltd. (2004) Summary page 2.
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 2.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 2.
- K033303: Wafer System, Spine Wave, Inc. (2004) Summary page 2.

## Most influential descendants
- K063606: Modification to Staxx FX System (2007), 11 descendants of its own
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own
- K202393: SpineJack Expansion Kit (2020), 3 descendants of its own
- K211238: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (2021), 2 descendants of its own

## Indications for use
The StaXx FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex Radiopaque Bone Cement.

Source page: https://510kreport.com/device/K053336
Methodology: https://510kreport.com/methodology