# K150408: V-Steady, V-Fast

- Pathway: 510(k) (Traditional)
- Applicant: G21, S.R.L.
- Decided: Dec 14, 2015 after 299 days
- Product code: LOD (Bone Cement)
- 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 P810020 (1984). 3 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050085: Osteopal V, Heraeus Kulzer,GmbH (2005) Summary page 5.

## Most influential descendants
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K222789: VADER® Pedicle System, G21 Cement (2023), 5 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own

## Indications for use
V-STEADY and V-FAST bone cements are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

Source page: https://510kreport.com/device/K150408
Methodology: https://510kreport.com/methodology