# K122175: Mendec Spine HV, Mendec Spine HV System

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: Mar 28, 2013 after 248 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 K002652 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 2.
- K093828: Kyph X HV-R Bone Cement, Medtronic, Inc. (2010) Summary page 2.
- K042415: Mendec Spine, Tecres S.P.A. (2005)

## Most influential descendants
- K230774: PERLA® TL System; TEKTONA® HV US Bone Cement (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K122175
Methodology: https://510kreport.com/methodology