# K241775: XeliteMed VertehighFix High Viscosity Spinal Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Xelite Biomed, Ltd.
- Decided: Sep 18, 2024 after 90 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). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K042415: Mendec Spine, Tecres S.P.A. (2005) Summary page 5.

## Most influential descendants
- K251896: XeliteMed SuperM-Fix Spinal Bone Cement (2026), 0 descendants of its own
- K243537: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (2025), 0 descendants of its own

## Indications for use
XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

Source page: https://510kreport.com/device/K241775
Methodology: https://510kreport.com/methodology