# K121876: Vertecem II Cement Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Aap Biomaterials GmbH
- Decided: Oct 19, 2012 after 114 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: 4 generations back to P810020 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090435: Vertecem, Teknimed, S.A. (2009) Summary page 1.
- K090460: Bonos Inject, Aap Biomaterials GmbH (2009) Summary page 1.

## Indications for use
The Vertecemn 11 Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporoisis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K121876
Methodology: https://510kreport.com/methodology