# K211238: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Jun 25, 2021 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: 15 generations back to K040583 (2004). 180 ancestors in all.
2 later devices descend 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)
- K202393: SpineJack Expansion Kit, Stryker Corporation (2020) Summary page 7.
- K072118: Stryker Vertaplex Radiopaque Bone Cement, Stryker Corp. (2007) Summary page 7.
- K192818: Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System, Stryker Corporation (2020) Summary page 7.

## Most influential descendants
- 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, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation. They are intended to be used in combination with Stryker Vertaplex® and Vertaplex® HV bone cement. Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with the SpineJack Expansion Kit, Vertaplex® Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Maged Type A vertebral compression fractures. Vertaplex® HV Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Vertaplex® High Viscosity (HV) Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with the SpineJack Expansion Kit, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

Source page: https://510kreport.com/device/K211238
Methodology: https://510kreport.com/methodology