# K153737: OSTEOPAL plus

- Pathway: 510(k) (Special)
- Applicant: Heraeus Medical GmbH
- Decided: Apr 22, 2016 after 116 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.
No later device cites it as a predicate yet.
0 of 4 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 4.

## Indications for use
OSTEOPALR® plus 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/K153737
Methodology: https://510kreport.com/methodology