# K223294: SpineJack® Expansion Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Dec 20, 2022 after 55 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: 16 generations back to K040583 (2004). 181 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211238: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement, Stryker Instruments (2021) Summary page 4.

## Most influential descendants
- 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, traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex and Vertaplex IV bone cement.

Source page: https://510kreport.com/device/K223294
Methodology: https://510kreport.com/methodology