# K243537: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

- Pathway: 510(k) (Traditional)
- Applicant: Xelite Biomed, Ltd.
- Decided: Apr 11, 2025 after 147 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: 5 generations back to K002652 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241775: XeliteMed VertehighFix High Viscosity Spinal Bone Cement, Xelite Biomed, Ltd. (2024) Summary page 5.

## Indications for use
The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which 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/K243537
Methodology: https://510kreport.com/methodology