# K181262: SpineJack Expansion Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vexim SA
- Decided: Aug 30, 2018 after 111 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: 11 generations back to K970097 (1997). 60 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132817: Kiva VCF Treatment System, Benvenue Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K223294: SpineJack® Expansion Kit (2022), 1 descendant of its own
- K250637: VCFix Spinal System (2025), 0 descendants of its own

## Indications for use
The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex and Vertaplex HV bone cements.

Source page: https://510kreport.com/device/K181262
Methodology: https://510kreport.com/methodology