# K202393: SpineJack Expansion Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Oct 20, 2020 after 60 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: 12 generations back to K970097 (1997). 61 ancestors in all.
3 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)
- K181262: SpineJack Expansion Kit, Vexim SA (2018) Summary page 4.

## Most influential descendants
- 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 cement.

Source page: https://510kreport.com/device/K202393
Methodology: https://510kreport.com/methodology