# K063438: Vspspn

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: Jan 17, 2007 after 64 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042415: Mendec Spine, Tecres S.P.A. (2005) Summary page 1.
- K042414: Visioplast Acrylic Resin, Tecres (2004) Summary page 1.

## Indications for use
Vspspn 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/K063438
Methodology: https://510kreport.com/methodology