# K050854: Palacos LV+G

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer,GmbH
- Decided: Jul 7, 2005 after 94 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
PALACOS® LV + G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Source page: https://510kreport.com/device/K050854
Methodology: https://510kreport.com/methodology