# K042691: Vertefix Vertebroplasty Procedure Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 8, 2005 after 405 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: 3 generations back to K002652 (2001). 4 ancestors in all.
189 later devices descend from it; 3 cite it directly.
0 of 194 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.
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 1.

## Most influential descendants
- K060300: Confidence High Viscosity Bone Cement (2006), 176 descendants of its own
- K102397: Kyphon Xpede Bone Cement (2011), 165 descendants of its own
- K150460: KYPHON (R) HV-R (R) Bone Cement (2015), 162 descendants of its own
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (2016), 159 descendants of its own
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (2016), 106 descendants of its own

## Indications for use
VertefixTM Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K042691
Methodology: https://510kreport.com/methodology