# K150582: Vertaplex® High Viscosity (HV) Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Jun 12, 2015 after 95 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032945 (2004). 3 ancestors in all.
53 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091606: Vertaplex HV (Single Pack and Dual Pack), Stryker Corp. (2009) Summary page 5.

## Most influential descendants
- K163032: Kyphon Xpede Bone Cement (2017), 52 descendants of its own
- K180700: KYPHON HV-R Bone Cement (2018), 51 descendants of its own
- K191148: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (2019), 50 descendants of its own
- K193011: CD Horizon™ Fenestrated Screw Set (2020), 41 descendants of its own
- K201362: CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (2020), 38 descendants of its own

## Recalls of this device
- Jun 14, 2016 · Class II · Z-2536-2016: The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if addit

## Indications for use
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).

Source page: https://510kreport.com/device/K150582
Methodology: https://510kreport.com/methodology