# K043518: Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: May 11, 2005 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: 1 generation back to K032945 (2004). 1 ancestor in all.
27 later devices descend from it; 6 cite it directly.
0 of 29 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
- K090211: Inflatable Bone Tamp (2009), 24 descendants of its own
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 (2010), 23 descendants of its own
- K103064: Avamax Vertebral Balloon (2011), 22 descendants of its own
- K131820: Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G (2013), 8 descendants of its own
- K122533: Osseoflex SB Inflatable Bone Tamp (2012), 8 descendants of its own

## Indications for use
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.

Source page: https://510kreport.com/device/K043518
Methodology: https://510kreport.com/methodology