# K070015: Cobalt V Radiopaque Vertebroplasty Bone Cement

- Pathway: 510(k) (Abbreviated)
- Applicant: Biomet Manufacturing Corp
- Decided: Nov 30, 2007 after 331 days
- Product code: LOD (Bone Cement)
- 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 P810020 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050085: Osteopal V, Heraeus Kulzer,GmbH (2005) Summary page 1.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.
- K051496: Cobalt Bone Cement, Biomet, Inc. (2005) Summary page 1.

## Indications for use
CobaltTM V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.

Source page: https://510kreport.com/device/K070015
Methodology: https://510kreport.com/methodology