# K192403: VK100 Percutaneous Vertebral Augmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Bonwrx, Ltd.
- Decided: Nov 8, 2019 after 66 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: 3 generations back to K002652 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 4.

## Indications for use
The VKl 00® Percutaneous Vertebral Augmentation System is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K192403
Methodology: https://510kreport.com/methodology