# K042415: Mendec Spine

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: Jun 9, 2005 after 275 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.
28 later devices descend from it; 5 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033801: Kyphx HV-R, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.

## Most influential descendants
- K062452: Kit Mendec Spine and Delivery System (2006), 18 descendants of its own
- K063248: Arcuate Vertebral Augmentation System (2007), 17 descendants of its own
- K070293: Benvenue VCF Osteo Coil System (2007), 10 descendants of its own
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K181262: SpineJack Expansion Kit (2018), 4 descendants of its own

## Indications for use
Mendec Spine is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporesis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K042415
Methodology: https://510kreport.com/methodology