# K091606: Vertaplex HV (Single Pack and Dual Pack)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Oct 23, 2009 after 142 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: 2 generations back to K032945 (2004). 2 ancestors in all.
59 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072118: Stryker Vertaplex Radiopaque Bone Cement, Stryker Corp. (2007) Summary page 1.

## Most influential descendants
- K150582: Vertaplex® High Viscosity (HV) Radiopaque Bone Cement (2015), 53 descendants of its own
- 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

## Indications for use
Vertaplex HV Radiopaque Bone Cement is indicated for the 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).

Source page: https://510kreport.com/device/K091606
Methodology: https://510kreport.com/methodology