# K050085: Osteopal V

- Pathway: 510(k) (Abbreviated)
- Applicant: Heraeus Kulzer,GmbH
- Decided: Sep 14, 2005 after 244 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: 2 generations back to P810020 (1984). 2 ancestors in all.
38 later devices descend from it; 5 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030903: Osteopal, Heraeus Kulzer GmbH & Co. KG (2003) Summary page 1.

## Most influential descendants
- K150408: V-Steady, V-Fast (2015), 28 descendants of its own
- 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
- K090460: Bonos Inject (2009), 8 descendants of its own

## Indications for use
OSTEOPAL® V bone cement is 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/K050085
Methodology: https://510kreport.com/methodology