# K090435: Vertecem

- Pathway: 510(k) (Special)
- Applicant: Teknimed, S.A.
- Decided: Dec 21, 2009 after 305 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
No predicates in its family tree.
49 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K161114: HIGH V+ (2017), 42 descendants of its own
- K180498: NuVasive Reline Fenestrated Screws, High V+ Bone Cement (2018), 41 descendants of its own
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (2019), 28 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- K103433: F20 (2011), 18 descendants of its own

## Indications for use
The Vertecem 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 osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K090435
Methodology: https://510kreport.com/methodology