# K072118: Stryker Vertaplex Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Dec 7, 2007 after 128 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: 1 generation back to K032945 (2004). 1 ancestor in all.
63 later devices descend from it; 2 cite 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)
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.

## Most influential descendants
- K091606: Vertaplex HV (Single Pack and Dual Pack) (2009), 59 descendants of its own
- 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

## Indications for use
Vertaplex Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty of 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/K072118
Methodology: https://510kreport.com/methodology