# K190766: PALACOS fast R+G

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical GmbH
- Decided: May 31, 2019 after 67 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)
- K031673: Refobacin -Palacos G, Heraeus Kulzer GmbH & Co. KG (2004) Summary page 4.

## Indications for use
PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement 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/K190766
Methodology: https://510kreport.com/methodology