# K091234: Skeltex Isv

- Pathway: 510(k) (Traditional)
- Applicant: Skeltex Technologies, Inc.
- Decided: Feb 16, 2010 after 295 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Skeltex ISV is intended for percutaneous delivery of PMMA bone cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions {metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K091234
Methodology: https://510kreport.com/methodology