# K063606: Modification to Staxx FX System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 13, 2007 after 133 days
- Product code: OBL (Cement, Bone, Pre-Formed, Modular, Polymeric, 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: 9 generations back to K970097 (1997). 39 ancestors in all.
11 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)
- K053336: Staxx FX System, Spine Wave, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K191709: V-STRUT Vertebral Implant (2020), 2 descendants of its own

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

Source page: https://510kreport.com/device/K063606
Methodology: https://510kreport.com/methodology